Clinical trial NCT02497300
Conditions: Chronic Kidney Disease Albuminuria
Keywords: Mineralocorticoid Receptor Antagonists Mineralocorticoid Effects
Sponsor: University of Alabama at Birmingham
Start date: 2015-03-01; Completion date: 2021-07-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Vascular endothelial dysfunction increases cardiovascular (CV) risk and contributes to the progression of chronic kidney disease (CKD). Mineralocorticoid receptor (MR) antagonists have been shown to improve endothelial function, as well as decrease CV mortality and proteinuria. The specific biochemical pathways that produce these pharmacological effects for MR antagonists, however, are poorly understood. This study investigates the effect of MR antagonism on endothelial function in patients with moderate (stage III) CKD using a randomized, controlled trial. Three specific aims are proposed: Aim 1: To determine if spironolactone improves endothelial function as compared to amiloride in patients with stage III CKD; Aim 2: To determine if oxidative stress is associated with changes in endothelial function by spironolactone compared to amiloride in patients with stage III CKD; and Aim 3: To determine if endothelial dysfunction contributes to albuminuria in patients with stage III CKD. The clinical relevance is to improve understanding of the mechanisms of kidney function decline in CKD in order to develop interventions to delay or prevent dialysis, which would translate into alleviating patient suffering, caregiver burden, and health care costs.

Detailed description:
Study participants with proteinuric, stage III CKD will be randomly assigned in a double-masked fashion to spironolactone 25mg daily or amiloride 5 mg daily for 6 weeks and then crossed over to the alternate study medication after a 1 month wash-out period. Vascular function will be assessed at baseline and the end of each 6 week treatment period by: 1) ultrasound guided flow-mediated dilation (FMD) of the brachial artery, 2) impedence cardiography, 3) pulse-wave velocity, 4) 24 hour ambulatory blood pressure monitoring, and 5) serum and urine biomarkers. Participants will undergo a total of 7 visits over 16-18 weeks; 3 of the 7 visits will involve vascular function testing.

A study visit where vascular function testing is to be performed will begin at 0800 in the morning and start with a vital sign assessment including height, weight, body fat percent, and left arm automated BP measurement followed by confirmation of fasting status and a brief past medical history. Each participant will then lie supine for 10 minutes in preparation for vascular function testing. Following the pulse wave velocity, impedence cardiography, and FMD measurements, the participant will have his/her blood and urine collected for laboratory testing. Laboratory testing will include \~20 mL of blood for plasma and serum testing. Participants will return 24 hour urine samples and have a 24 hour ambulatory monitor placed. This entire visit is expected to take 2 hours.

Study visits where vascular function testing will not be performed (e.g., screening visit, visit 2, visit 4, and visit 5; should last 30 minutes and involve a medication assessment, vital sign check, and blood collection for serum potassium (\~4 mL of blood).

All study medication will be prepared by the the University of Alabama (UAB) Research Pharmacy in matching capsules and placed in pill bottles labeled "A" and "B". The order of medication dispensing will follow simple randomization using an a priori randomization list prepared by the research pharmacy. All study personnel with participant interaction are masked to the order of study medication.

Arms: arm 1: Participants will be randomized to spironolactone 25mg daily for the 1st or 2nd 6 week treatment period. arm 2: Participants will be randomized to amiloride 5mg daily for the 1st or 2nd 6 week treatment period.
Interventions: intervention 1: Spironolactone intervention 2: Amiloride
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_000.pdf: 
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Human Subjects Protocol (HSP) 
Form Version: October 15, 2008 
 
 You are applying for IRB review of the research described in this form. 
 To avoid delay, respond to all items in order and include all required approvals and documents. 
 To complete the form, click the underlined areas and type or paste in your text; double-click 
checkboxes to check/uncheck. For more tips, see www.uab.edu/irb/forms. 
 Mail or deliver all materials to AB 470, 701 20th Street South, Birmingham, AL 35294-0104. 
 
Indicate the type of review you are applying for: 
 Convened (Full) IRB or 
 Expedited—See the Expedited Category Review Sheet, and indicate the 
category(ies) here: 
1 
2 
3 
4 
5 
6 
7 
 
 
1. IRB Protocol Title:  Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney 
Disease  
 
2. Investigator, Contacts, Supervisors 
a. Name of Principal Investigator: Eric Judd 
 
 
Degree(s)/Title: MD/Instructor BlazerID: ejudd 
 
Dept/Div: Medicine/Nephrology Mailing Address: Paula, Rm 223   UAB ZIP: 0007 
 
 
Phone: 975-9676 
Fax: 975-8879 
E-mail:ejudd@uab.edu 
 
b. Name of Contact Person: Felice Cook Title: Program Coordinator II Phone: 4-1400 
E-mail: fycook@uab.edu  
 
 
 
Fax: 4-1302 
Mailing Address (if different from that of PI, above): CH19, Room 115 
INVESTIGATOR ASSURANCE STATEMENT & SIGNATURE 
By my signature as Principal Investigator, I acknowledge my responsibilities for this Human 
Subjects Protocol, including:  
 Certifying that I and any Co-Investigators or Other Investigators comply with reporting 
requirements of the UAB Conflict of Interest Review Board;  
 Certifying that the information, data, and/or specimens collected for the research will be 
used, disclosed and maintained in accordance with this protocol and UAB policies;   
 Following this protocol without modification unless (a) the IRB has approved changes prior 
to implementation or (b) it is necessary to eliminate an apparent, immediate hazard to a 
participant(s);  
 Verifying that all key personnel listed in the protocol and persons obtaining informed 
consent have completed initial IRB training and will complete continuing IRB training each 
year; 
 Verifying that all personnel are licensed/credentialed for the procedures they will be 
performing, if applicable; 
 Certifying that I and all key personnel have read the UAB Policy/Procedure to Ensure 
Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the 
IRB, Institutional Officials, and Regulatory Agencies and understand the procedures for 
reporting;  
 Applying for continuing review of the protocol at least annually unless directed by the IRB 
to apply more frequently;  
 Conducting the protocol as represented here and in compliance with IRB determinations 
and all applicable local, state, and federal law and regulations; providing the IRB with all 
information necessary to review the protocol; refraining from protocol activities until 
receipt of initial and continuing formal IRB approval.  
 
Signature of Investigator:  
 
 
 
 
 
 
Date: 
 
 


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c. List all staff who will be involved with the design, conduct, and reporting of the 
research, their degree(s) and job title, and any additional qualifications.  Include 
individuals who will be involved in the consent process. Repeat the table below for 
each individual. 
Note. For studies involving investigational drugs, include all investigators who will 
be listed on FDA Form 1572 and attach a copy, if applicable. Send the IRB a copy 
of Form 1572 anytime you update the form with the FDA. 
 
Role:  
Co- -OR- 
Other –AND/OR- 
Consent Process 
 Full Name: Eric Judd 
Primary UAB Dept.: 
(Employer if not UAB)  
Medicine 
Degree(s) / Job Title: M.D./ Instructor 
Additional Qualifications 
pertinent to the study: 
      
 
Role:  
 
Co- -OR- 
Other –AND/OR- 
Consent Process 
 Full Name: David A. Calhoun 
Primary UAB Dept.: 
(Employer if not UAB)  
Medicine 
Degree(s) / Job Title: M.D./Professor 
Additional Qualifications 
pertinent to the study: 
      
 
Role:  
 
Co- -OR- 
Other –AND/OR- 
Consent Process 
 Full Name: Michael Allon 
Primary UAB Dept.: 
(Employer if not UAB)  
Medicine 
Degree(s) / Job Title: M.D./Professor 
Additional Qualifications 
pertinent to the study: 
      
 
Role:  
 
Co- -OR- 
Other –AND/OR- 
Consent Process 
 Full Name: Tanja Dudenbostel 
Primary UAB Dept.: 
(Employer if not UAB)  
Medicine 
Degree(s) / Job Title: M.D./Assistant Professor 
Additional Qualifications 
pertinent to the study: 
      
Additional Qualifications 
pertinent to the study: 
      
 
Role:  
 
Co- -OR- 
Other –AND/OR- 
Consent Process 
 Full Name: Mohammed Siddiqui 
Primary UAB Dept.: 
(Employer if not UAB)  
Medicine 
Degree(s) / Job Title: M.D./Postdoctoral Fellow 
Additional Qualifications 
pertinent to the study: 
      


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Role:  
 
Co- -OR- 
Other –AND/OR- 
Consent Process 
 Full Name: Gary Cutter 
Primary UAB Dept.: 
(Employer if not UAB)  
Biostatistics 
Degree(s) / Job Title: Ph.D./Professor 
Additional Qualifications 
pertinent to the study: 
      
 
Role:  
 
Co- -OR- 
Other –AND/OR- 
Consent Process 
 Full Name: Rakesh Patel 
Primary UAB Dept.: 
(Employer if not UAB)  
Molecular & Cellular Pathology 
Degree(s) / Job Title: Ph.D./Professor 
Additional Qualifications 
pertinent to the study: 
      
 
 
Role:  
 
Co- -OR- 
Other –AND/OR- 
Consent Process 
 Full Name: Salam Madi 
Primary UAB Dept.: 
(Employer if not UAB)  
Medicine 
Degree(s) / Job Title: MSc/Research Coordinator 
Additional Qualifications 
pertinent to the study: 
      
 
 
d. Is the principal investigator a student, fellow, or resident?  
Yes 
No 
 
If Yes, complete items below and obtain signature of faculty advisor or 
supervisor: 
Supervisor's Name:  
Degree(s) / Job Title:  
Additional Qualifications 
pertinent to the study: 
 
Telephone:  
E-Mail:  
Signature:  
 
e. Describe the principal investigator's activities related to this protocol and 
provisions made by the PI to devote sufficient time to conduct the protocol: 
 
This clinical trial constitutes the primary project for Dr. Judd’s career development award, for 
which he will receive 80% dedicated research time for 5 years.  Dr. Judd will oversee all aspects of 
the study including the consent process, vascular function testing, biochemical specimen collection 
and storage, study visits, dispensing of study medication, data storage, and data analysis.    
 
f.  Is medical supervision required for this research?  
Yes 
No 
 
If Yes, who will provide the supervision? 
 PI will provide -OR- Name:      
Telephone: 
 
If other than PI, obtain signature of person providing medical supervision: 
Signature   
 
 
 
 
 
 
 


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g. Describe the process that ensures that all persons assisting with the research are 
adequately informed about the protocol and their research-related duties and 
functions: The co-investigators contributed to the design of the proposed protocol.  The protocol 
roles of all study personnel will be reviewed prior to study initiation, annually and with any 
change(s) in protocol. 
 
3. Funding 
Is this study funded?  
Yes 
No 
If No, specify that costs of the study will be covered by funds from the UAB 
department or other source named:  
 
 
 
 
If Yes, attach one copy of completed application or request for funding sent to 
sponsor, and complete a-d.  
a. Title of Grant or Contract:  Vascular effects of mineralocoriticoid receptor antagonism in 
kidney disease 
b. PI of Grant or Contract: Eric Judd 
c. Office of Grants & Contracts Administration Link or Tracking Number: Pending 
 
(or enter "Pending" and provide upon receipt from OGCA) 
d. Sponsor, Funding Route (check and describe all that apply): 
 Gov’t Agency or Agencies—Agency name(s): National Institutes of Health 
 NIH Coop. Group Trial—Group name:      
 Private Nonprofit (e.g., Foundation)—Name:       
 Industry, investigator-initiated—Name:      Describe the funding 
arrangement:       
 
Note. Western IRB reviews industry-sponsored protocols unless the 
investigator initiated the research, or the study qualifies for expedited review 
or involves gene therapy.  
 UAB Departmental/Division Funds—Specify: 
 
4. Conflict of Interest—Human subjects research involving a disclosed financial 
interest is subject to IRB review following review by the Conflict of Interest 
Review Board.  
The following definitions are used for Item #4: 
Immediate family means spouse or a dependent of the employee. Dependent is any 
person, regardless of his or her legal residence or domicile, who receives 50% or 
more of his or her support from the public official or public employee or his or her 
spouse or who resided with the public official or public employee for more than 180 
days during the reporting period. 
Financial Interest Related to the Research means financial interest in the 
sponsor, product or service being tested, or competitor of the sponsor. 
For each investigator and staff member who are involved in the design, conduct and 
reporting of the research (2a. and c.) answer the questions below: (Repeat the 
section below for each individual) 
 
Name: Eric Judd 
Do you or your immediate family have any of the following? (check all that apply) 
 An ownership interest, stock options, or other equity interest related 
to the research of any value. 
 


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  Compensation related to the research unless it meets two tests: 
 Less than $10,000 in the past year when aggregated for the 
immediate family. 
 Amount will not be affected by the outcome of the research.  
 
 Proprietary interest related to the research including, but not limited 
to, a patent, trademark, copyright, or licensing agreement.  
 
 Board of executive relationship related to the research, regardless of 
compensation. 
 
 
Name: David A. Calhoun 
Do you or your immediate family have any of the following? (check all that apply) 
 An ownership interest, stock options, or other equity interest related 
to the research of any value. 
 
  Compensation related to the research unless it meets two tests: 
 Less than $10,000 in the past year when aggregated for the 
immediate family. 
 Amount will not be affected by the outcome of the research.  
 
 Proprietary interest related to the research including, but not limited 
to, a patent, trademark, copyright, or licensing agreement.  
 
 Board of executive relationship related to the research, regardless of 
compensation. 
 
 
Name: Michael Allon 
Do you or your immediate family have any of the following? (check all that apply) 
 An ownership interest, stock options, or other equity interest related 
to the research of any value. 
 
  Compensation related to the research unless it meets two tests: 
 Less than $10,000 in the past year when aggregated for the 
immediate family. 
 Amount will not be affected by the outcome of the research.  
 
 Proprietary interest related to the research including, but not limited 
to, a patent, trademark, copyright, or licensing agreement.  
 
 Board of executive relationship related to the research, regardless of 
compensation. 
 
 
Name: Tanja Dudenbostel 
Do you or your immediate family have any of the following? (check all that apply) 
 An ownership interest, stock options, or other equity interest related 
to the research of any value. 
 
  Compensation related to the research unless it meets two tests: 
 Less than $10,000 in the past year when aggregated for the 
immediate family. 
 Amount will not be affected by the outcome of the research.  
 
 Proprietary interest related to the research including, but not limited 
to, a patent, trademark, copyright, or licensing agreement.  
 
 Board of executive relationship related to the research, regardless of 
compensation. 
 
 
 


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Name: Salam Madi 
Do you or your immediate family have any of the following? (check all that apply) 
 An ownership interest, stock options, or other equity interest related 
to the research of any value. 
 
  Compensation related to the research unless it meets two tests: 
 Less than $10,000 in the past year when aggregated for the 
immediate family. 
 Amount will not be affected by the outcome of the research.  
 
 Proprietary interest related to the research including, but not limited 
to, a patent, trademark, copyright, or licensing agreement.  
 
 Board of executive relationship related to the research, regardless of 
compensation. 
 
 
Name: Mohammed Siddiqui 
Do you or your immediate family have any of the following? (check all that apply) 
 An ownership interest, stock options, or other equity interest related 
to the research of any value. 
 
  Compensation related to the research unless it meets two tests: 
 Less than $10,000 in the past year when aggregated for the 
immediate family. 
 Amount will not be affected by the outcome of the research.  
 
 Proprietary interest related to the research including, but not limited 
to, a patent, trademark, copyright, or licensing agreement.  
 
 Board of executive relationship related to the research, regardless of 
compensation. 
 
 
Name: Gary Cutter 
Do you or your immediate family have any of the following? (check all that apply) 
 An ownership interest, stock options, or other equity interest related 
to the research of any value. 
 
  Compensation related to the research unless it meets two tests: 
 Less than $10,000 in the past year when aggregated for the 
immediate family. 
 Amount will not be affected by the outcome of the research.  
 
 Proprietary interest related to the research including, but not limited 
to, a patent, trademark, copyright, or licensing agreement.  
 
 Board of executive relationship related to the research, regardless of 
compensation. 
 
 
Name: Rakesh Patel 
Do you or your immediate family have any of the following? (check all that apply) 
 An ownership interest, stock options, or other equity interest related 
to the research of any value. 
 
  Compensation related to the research unless it meets two tests: 
 Less than $10,000 in the past year when aggregated for the 
immediate family. 
 Amount will not be affected by the outcome of the research.  
 
 Proprietary interest related to the research including, but not limited 
to, a patent, trademark, copyright, or licensing agreement.  
 


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 Board of executive relationship related to the research, regardless of 
compensation. 
 
 
 
If you checked any of the above, a financial interest disclosure has to be submitted 
to or currently be on file with the CIRB. A completed CIRB Evaluation has to be available 
before the IRB will conduct its review.  
 
5. Locations Involved 
a. Describe the facilities available for the conduct of the research. For research on 
UAB campus, include building names and room numbers: 115 Community Health 
Services Building; UAB Outreach Laboratory Services, O’Brien Center Bioanalytical Core 
 
 
b. Indicate all "performance sites" that will provide space, services, facilities, 
potential or actual participants, or other support for this protocol.  
 The Kirklin Clinic (TKC) 
 University of Alabama Hospital (UAHosp) 
 The Children's Hospital of Alabama (TCHA) 
 Callahan Eye Foundation Hospital (CEFH) 
 UAB Highlands 
 Jefferson County Dept. of Health (JCDH) 
 Birmingham Veterans Affairs Medical Center (BVAMC) 
 General Clinical Research Center (GCRC)—inpatient  
 General Clinical Research Center (GCRC)—outpatient  
 General Clinical Research Center (GCRC) at The Kirklin Clinic (TKC) 
 Other (i.e., Any performance site not listed above, including those covered by 
subcontracts related to this protocol)—Describe: CHSB Room 115 
 
c. Is this study a clinical trial requiring clinical services at one of the performance 
sites listed in Item b above? 
Yes 
No 
If Yes, Fiscal Approval Process (FAP)-designated units complete a FAP submission 
and send to fap@uab.edu. For more on the UAB FAP, see www.uab.edu/ohr.  
 
d. Is this a field study?  
Yes 
No 
If Yes, describe the community:      
 
e. Is the study to be undertaken within a school, business, or other institution that 
does not have an institutional review board?  
Yes 
No 
If Yes, attach a statement of any contacts with and approvals from the 
appropriate institution officials.  
 
Note. Documentation of all such approvals must be received by the UAB OIRB 
before IRB approval will be issued. 
 
f. Has this protocol or project been reviewed by another IRB, similar review board, or 
departmental review committee(s) that authorizes the use of its patient 
populations?  
Yes 
No 
 
If Yes, provide name of the review board(s):       
and for each board listed,  
 
enter either the date of latest approval(s) or “PENDING”:      or reasons not 
approved:     .  If this protocol is subsequently rejected or disapproved by 
another review board, the UAB IRB must be notified promptly. 


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Attach copies of approvals/disapprovals. 
 
g. Will any of the participants be from the Birmingham Veterans Affairs Medical 
Center?  
Yes 
No 
If Yes, attach VA IRB approval or notification from the VA Research and 
Development Department that the study has been submitted to the VA IRB for 
review. 
 
h. Will the study be conducted at or recruit participants from the Jefferson County 
Department of Public Health (JCDH)?  
Yes 
No 
If Yes, attach notification that the protocol has been approved by JCDH or the 
Alabama Department of Public Health IRB. 
 
6. Multi-Site Studies 
a. Is the investigator the lead investigator of a multi-site study?  
Yes 
No 
b. Is UAB a coordinating site in a multi-site study? 
Yes 
No 
c. If you answered Yes to a or b, describe the management of information obtained 
in multi-site research that might be relevant to the protection of participants. 
Include, at a minimum, the following items:  
o IRB approvals from other sites 
o Unanticipated problems involving risks to participants or others. (For 
example, if there is an unanticipated problem involving risks to participants 
or others, which site is responsible for reporting it?)  
o Interim results. 
o Protocol modifications.  
      
 
7. Drugs: Will any drugs or supplements be used/studied in this protocol?  
Yes 
No 
If Yes, attach the Drug Review Sheet.  
 
8. Devices: Will any devices be studied in this protocol or used for a purpose other than 
for which they were approved by the FDA?  
Yes 
No  
If Yes, attach the Device Review Sheet. 
 
9. Special Approvals 
a. Does this project involve the use of radioisotopes?  
Yes 
No 
If Yes, attach documentation of approval from the Radiation Safety Division. 
 
b. Does this project include patients with contagious infections (e.g., mumps, 
measles, chickenpox, TB, meningitis)?  
Yes 
No 
If Yes, attach documentation of approval from Chairman of the Infection Control 
Committee of the appropriate facilities. 
 
c. Does this project involve obtaining remnant biopsy or surgical material from the 
Department of Pathology or any other source?  
Yes 
No 
If Yes, attach documentation of approval from the entity or individual providing 
the materials (e.g., the UAB Division of Anatomic Pathology Release of Pathologic 
Materials). 
 
d. Does this project require obtaining any remnant clinical laboratory specimens, 
body fluids, or microbiological isolates from the Department of Pathology or any 
other source?  
Yes 
No 


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If Yes, attach documentation of approval from the entity or individual providing 
the materials (e.g., the UAB Division of Laboratory Medicine Release of Pathologic 
Materials). 
 
e. Does this project use stored (existing) specimens from a repository?  
Yes 
No 
If Yes, attach documentation of approval for use of specimens, and describe how 
existing specimens are labeled:       
 
10. Use of Specimens  
Does this project involve collecting specimens from participants and storing them for 
future research?  
Yes 
No 
If Yes, complete a-h. If no, skip to Item 11 
a. How will specimens be obtained, processed, distributed, and stored?  
Blood and urine from 3 study visits will be labeled and stored in a Fisherbrand cryo/freezer 
box in a temperature controlled and monitored freezer located in the Ziegler Research 
Building (Rm 510) 
 
b.  How will specimens be labeled (e.g., unique identifier, medical record number, 
Social Security number, name, date of birth)?  
Specimens will be labeled by study name, participant study number, and date of collection. 
 
c.  How will clinical data associated with the specimens be collected and stored?  
Clinical data associated with the specimens will be kept in the study database.  The database 
will be maintained on a computer with access restricted by password protection to study staff.  
A non-specific participant number will be generated for each participant.  The list linking the 
participant numbers to the participant identifiers will kept in a secure location with password-
protection and only the PI and designated study personnel will have access to this list.  Data 
will be stored with use of the participant numbers without identifiable labels such as names, 
medical record number or social security number. 
 
d.  What participant-identifying information will be collected and linked to the 
specimens?  
Participant name and date of birth will be recorded in the list linking participant number to 
the participant identifiers. 
 
e.  What steps will be taken to maximize the confidentiality of linked identifiers? 
For example, procedures could include using a password-protected computer 
database to link identifiers, with limited personnel knowledgeable of the 
password, or coded identifiers released without the ability to link to clinical data 
(also called "stripped" or "anonymized" specimens).  
As described in part c, data collected throughout the study will be stored in a database 
maintained on a computer with access restricted by password protection to study staff.  The 
specimens will be labeled with de-identified codes (participant number and date of collection). 
 
f.  Will specimens be shared with other investigators in the future?  
Yes 
No  
If Yes, what identifiers, clinical information and demographic information will 
be shared; or will the specimens be stripped of identifiers (i.e., anonymized)? 
Also if yes, outline your procedure for assuring IRB approval for release and 
use prior to release of specimens.  
 
 Specimens that are provided to other investigators will remain stripped of identifiers.  
Participant demographics including age, gender, race, and comorbidities will also be provided 
in a de-identified form using participant study number (e.g., CKD1501).  
 


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 Note. Investigators who receive and/or use these specimens must document 
approval from the appropriate IRB(s) before the specimens may be released. 
 
g.  Will biological samples be stored for future use? 
Yes 
No 
If Yes, indicate whether they will be used for the disease under study in this 
protocol or research on other diseases.  
Blood and urine samples will be stored with the potential for future testing for the disease 
under this study protocol (e.g., vascular function in chronic kidney disease).  
 
h. Is genetic testing planned?  
Yes 
No 
If Yes, describe the planned testing here and see "DNA/Genetic Testing" in the 
Guidebook for consent requirements. 
Cells from the blood sample will be stored for the potential to test for specific 
genetic variations (i.e., polymorphisms that alter the response to 
spironolactone). 
 
 
11. Gene Therapy   
Does this project involve gene therapy or administering recombinant materials to 
humans?  
Yes 
No 
 
If Yes, submit the Gene Therapy Project Review Panel Report –OR- If this is a 
vaccine trial that is exempt from the NIH Guidelines For Research Involving 
Recombinant DNA Molecules, submit the Protocol Oversight Review Form For Clinical 
Vaccine Trials. 
 
12.  HIPAA Privacy and Security  
 
Will the PI or others obtain, review, or make other use of participants' "personal 
health information" (i.e., information, whether oral or recorded in any form or 
medium that (a) is created or received by a health care provider and (b) relates to 
past, present, or future physical or mental health or condition of an individual; or 
provision of health care; or payment for provision of heath care)?  
Yes 
No 
 
 
If Yes, complete a-e as described. 
 
a. Will the data/information be stored or managed electronically (on a computer)? 
 
 
Yes 
No 
 
b. Is the principal investigator requesting that the UAB IRB waive patient HIPAA 
authorization from another institution or entity (e.g., insurance company, 
collaborating institution).  
Yes 
No 
 
If Yes, attach copy of privacy notices from institution/entity, and provide the 
name of institution/entity:       
 
c. Indicate which, if any, of the listed entities below would provide information or 
maintain health information collected for this protocol and/or where health 
information that been collected will be stored/maintained. 
 The Kirklin Clinic 
 University of Alabama Hospital 
 The Children’s Hospital of Alabama 
 Callahan Eye Foundation Hospital 
 UAB Highlands 
 Jefferson County Department of Health  
 School of Dentistry 


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 School of Health Professions 
 School of Medicine 
 School of Nursing 
 School of Optometry 
 University of Alabama Health Services Foundation 
 UAB Health Centers 
 Viva Health 
 Ophthalmology Services Foundation 
 Valley Foundation  
 Medical West - UAB Health System Affiliate 
 
Health System Information Systems: 
 HealthQuest 
 Cerner Millennium (Lab, Radiology, UED, Surgery) 
 EMMI - Master Member Index 
 Horizon - IPV (IVR/CDA/CRIS) 
 CareFlow Net 
 Eclipsys (PIN) 
 IMPACT 
 None—If None, skip to Item 13. 
 
d.  Indicate which of the listed identifiers would be associated/linked with the 
protected health information (PHI) used for this protocol.  
 
 
 Names 
 Geographic subdivisions smaller than a State 
 Elements of dates (except year) related to an individual 
 Telephone numbers 
 Fax numbers 
 Email addresses 
 Social security numbers 
 Medical record numbers 
 Health plan beneficiary numbers 
 Account numbers 
 Certificate/license numbers 
 Vehicle identifiers and serial numbers 
 Device identifiers and serial numbers 
 Biometric identifiers 
 Web universal resource locators (URLs) 
 Internet protocol address numbers 
 Full-face photographic images  
 Any other unique identifying number—Describe:       
 
Note. Codes are not identifying as long as the researcher cannot link the data 
to an individual 
 None—If None, skip to Item 13. 
 
e. Choose one plan to describe your use of the personal health information: 
 The data collected meet the specifications for a “limited data set” 
—Attach Data Use Agreement or Business Associate Agreement 
 
 Research staff will obtain authorization from each patient to use the information 


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—Attach Patient Authorization form, complete except for patient name and IRB 
protocol number 
 
 PI requests Waiver of Patient Authorization to use the information 
 
—Attach Waiver of Authorization and Informed Consent form 
 
PROPOSED RESEARCH 
• The IRB will not accept grant applications and/or sponsor's protocols in lieu of the 
items as outlined below.  
• Do not separate responses from items. Instead, insert your response to each item 
below the item, keeping the information in the order of this form. 
• Number each page of the Human Subjects Protocol (i.e., Page X of Y). 
 
13. Purpose—in nontechnical, lay language  
Summarize the purpose and objectives of this protocol, including any related 
projects, in one short paragraph. 
Few therapies exist to prevent or slow the progression of chronic kidney disease, a disease with a 
large public health burden.  This project investigates the vasculature as a novel target for chronic 
kidney disease treatment. 
 
14. Background—in nontechnical, lay language 
Summarize in 2-3 paragraphs past experimental and/or clinical findings leading to the 
formulation of this study. Include any relevant past or current research by the 
Principal Investigator. For drug and device studies summarize the previous results 
(i.e., Phase I/II or III studies). 
Chronic kidney disease, an inpairment in kidney function beyond age-expected decline, is 
commonly attributed to kidney damage from diabetes mellitus and/or hypertension.  While the 
direct mechanism(s) of kidney injury resulting from these comorbidities has yet to be defined, it 
has been hypothesized that the vasculature is involved in kidney function.  This hypothesis is 
supported by the evidence that the one proven therapy for chronic kidney disease, namely 
angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), 
improves vascular function.   
 
In our study of patients with resistant hypertension, we have shown that vascular function 
improves with the use of spironolactone, a mineralocorticoid receptor antagonist.  Spironolactone 
has also been shown to reduce urinary protein loss in patients with chronic kidney disease.  
Therefore, it is reasonable to suppose that spironolactone can improve vascular function in 
patients with chronic kidney disease.  Currently spironolactone is used sparingly in early stages of 
chronic kidney disease and is avoided in late stages of chronic kidney disease due to the risk of 
raising serum potassium levels.  If spironolactone improves vascular function in patients with 
moderate stages of chronic kidney disease, as it has been shown to do in patients with resistant 
hypertension, then defining this mechanism would open new therapeutic avenues for patients with 
chronic kidney disease.   
  
 
15. Participants (Screening and Selection) 
a. How many participants are to be enrolled at UAB? 62  
If multi-center study, total number at all centers:      
 
b. Sex: 50% Male 
Race/Ethnicity: All races and ethnicities in the Birmingham area will be enrolled.  Enrollment is 
expected to be composed of 65% African American (chronic kidney disease is more prevalent 
among African Americans). 


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Age: 19-65 years of age 
Health status: Participants with a moderate stage of chronic kidney disease 
 
Note. If data from prior studies indicate differences between the genders or among 
racial/ethnic groups in the proposed research or if there are no data to support or to 
negate such differences, Phase 3 clinical trials will be required to include sufficient 
and appropriate entry of gender and racial/ethnic subgroups so that trends detected 
in the affected subgroups can be analyzed. If ethnic, racial, and gender estimates are 
not included in the protocol, a clear rationale must be provided for exclusion of this 
information. If prior evidence indicates that the results will not show gender or racial 
differences, researchers are not required to use gender or race/ethnicity as selection 
criteria for study participants. They are, however, encouraged to include these 
groups. See Section II. Policy of the NIH POLICY AND GUIDELINES ON THE 
INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH – 
Amended, October, 2001) for further details.  
 
c. From what population(s) will the participants be derived?  
Participants will be primarily recruited from a database of former and active patients of the UAB 
Hypertension Clinic totaling over 1400 patients, over 200 of which have eGFRs < 60 
mL/min/1.73m2.  Additional recruitment will come from a database of patients seen in the CKD 
clinic at the Kirklin clinic and the PI’s renal clinics both at the Kirklin Clinic and at Cooper 
Green.     
 
Describe your ability to obtain access to the proposed population that will allow 
recruitment of the necessary number of participants: 
The PI has maintained a database of hypertension patients while working in Dr. David Calhoun’s 
Hypertension Clinic at the Kirklin Clinic.  A letter signed by Dr. David Calhoun and Dr. Eric 
Judd will be mailed to potential participants identified in this database.  The PI will recruit 
directly from his clinics at the Kirklin Clinic and at Cooper Green, where he is an attending in the 
renal clinic.  A letter signed by Dr. Eric Judd and Dana Rizk, the director of the CKD clinic at the 
Kirklin Clinic, will be mailed to potential participants identified in the CKD database.  
 
 
Describe the inclusion/exclusion criteria: 
Table 1. Study inclusion and exclusion criteria 
Inclusion 
Criteria 
 Adults (19-65 years of age) 
 CKD (eGFR 25-60 mL/min/1.73m2) with urine ACR > 30 mg/gCKD (eGFR > 60 
mL/min/1.73m2) with urine ACR ≥ 300 mg/g 
Exclusion 
Criteria 
 Severe HTN (office BP ≥ 160/100 mm Hg) 
 Hypotension (office BP < 110/70 mm Hg) 
 Serum potassium > 5 mEq/L 
 History of arrhythmia, including atrial fibrillation 
 Pregnant or breast feeding woman 
 DM type 1  
 DM type 2 with hemoglobin A1C ≥ 6.5 % 
 Dementia or cognitive impairment prohibiting informed consent 
 History of ischemic stroke, unstable angina, or myocardial infarction within the 
past 6 months 
 Allergy or intolerance to spironolactone or amiloride 
 Use of an MR antagonist or an epithelial sodium channel blocking medication 
within the last month 


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 Known primary aldosteronism or renal artery stenosis 
ACR = albumin-to-creatinine ratio, HTN = hypertension, BP = blood pressure, DM = diabetes 
mellitus, MR = mineralocorticoid receptor 
Patients with severe hypertension (office BP > 160/100 mm Hg) are excluded due to 1) the 
possibility of requiring blood pressure medication changes during the study period, 2) direct 
effects of blood pressure on vascular function testing, and 3) increased cardiovascular risk leading 
to potential serious adverse events.  Patients with hypotension (office BP < 110/70 mm Hg) were 
excluded due to an expected drop in blood pressure with administration of spironolactone and/or 
amiloride. 
 
d. If participants will comprise more than one group or stratification, describe each 
group (e.g., treatment/intervention, placebo, controls, sham treatment) and 
provide the number of participants anticipated in each group. 
 
This clinical trial follows a cross-over design.  All participants are scheduled to receive both study 
medications in series with randomization to the initiating therapy (See Figure 2). 
 
e. Indicate which, if any, of the special populations listed below will be involved in 
the protocol. Include the Special Populations Review Form (SPRF) if indicated. 
 Pregnant Women: Attach SPRF—Pregnant Women, Fetuses, 
Neonates/Nonviable Neonates 
 Fetuses: Attach SPRF—Pregnant Women, Fetuses, Neonates/Nonviable 
Neonates 
 Neonates/Nonviable Neonates: SPRF—Pregnant Women, Fetuses, 
Neonates/Nonviable Neonates 
 Prisoners: Attach SPRF—Prisoners 
 
 Minors (<19 years old): Attach SPRF—Minors 
 Employees or students at institution where research conducted 
 Persons who are temporarily decisionally impaired  
 Persons who are permanently decisionally impaired (e.g., mentally retarded) 
 
 
 Non-English Speakers 
For each box checked, describe why the group is included and the additional 
protections provided to protect the rights and welfare of these participants who 
are vulnerable to coercion:      
 
f. List any persons other than those directly involved in the study who will be at risk. 
If none, enter "None": None 
 
g. Describe the process  (e.g., recruitment, chart review) that will be used to seek 
potential participants (e.g., individuals, records, specimens). Research recruitment 
by non-treating physicians/staff may require completion of Partial Waiver of 


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Authorization for Recruitment/Screening. (See 
http://main.uab.edu/show.asp?durki=61981.) 
For patients identified as potential participants through the hypertension and CKD 
databases, study personnel will review the medical history including the medical record in order 
to identify exclusion criteria.  Eligible participants who meet inclusion and exclusion criteria after 
this screening process will be mailed a letter co-signed by Drs. Judd and Calhoun for the HTN 
database and Drs. Judd and Rizk (Dr. Dana Rizk is the Director of the CKD clinic at the Kirklin 
Clinic) for the CKD database.  Potential participants will be contacted by phone to set up a 
screening visit where an investigator will review the risks and benefits of participation in a formal 
consenting process.   
 
Patients recruited from the PI’s Kirklin Clinic or Cooper Green clinic will have the study 
and its associated risks and benefits introduced by the PI during a regularly scheduled follow-up 
visit.  Patients interested in participating will have a screening visit scheduled where informed 
consent will occur. 
 
Patients who are scheduled to see a nephrologist at the Kirklin clinic will be prescreened 
using chart review in Impact to assess eligibility.  With approval from the patient’s nephrologist, 
patients who are eligible will be contacted either by phone or in person at their clinic visit.  If 
interested, potential participants will be scheduled for a screening visit where the informed 
consent process takes place.  As part of the consenting process participants are presented with a 
copy of the informed consent and are allowed an unlimited amount of time before deciding to 
proceed with the study.   
 
In order to meet recruitment goals, the electronic health record system for University of 
Alabama Hospital and Kirklin Clinic will be screened using i2b2 in order to generate a list of 
potential study candidates.  Once this list has been truncated further by chart review, the primary 
care doctor and/or primary nephrologist at UAB will be contacted to approve sending the patient 
a letter in the mail.  The recruitment letter is attached. 
 
h. If you will use recruitment materials (e.g., advertisements, flyers, letters) to reach 
potential participants, attach a copy of each item. If not, identify the source (e.g., 
databases) from which you will recruit participants.  Eligible participants identified in 
the hypertension and CKD databases will receive a letter alerting them to future contact by study 
personnel.   Other participants will be recruited directly from the PI (Dr. Eric Judd’s) Kirklin 
Clinic and Cooper Green clinic.  Flyers will be posted in designated areas at Cooper Green, UAB 
campus, and the Kirklin Clinic.    
 
i. Describe the procedures for screening potential participants.  
The medical history will be reviewed with the potential participant in a standard of care clinic 
visit.  If the patient agrees to participate, an investigator will review the consent form in person 
with the volunteer during a screening visit.  For potential participants identified in the databases, 
their medical records will be obtained through Horizon or Impact in order to identify exclusion 
criteria.  Review of medical records will be limited to study personnel (either the PI, sub-
investigator, or study coordinator).   
 
16. Protocol Procedures, Methods, and Duration of the Study—in nontechnical 
language 
a.  Describe the study methodology that will affect the participants—particularly in 
regard to any inconvenience, danger, or discomfort. 
Study participants with proteinuric, CKD will be randomly assigned in a double-masked fashion 
to spironolactone 25mg daily or amiloride 5 mg daily for 6 weeks and then crossed over to the 
alternate study medication after a 1 month wash-out period (See Figure 1).  Vascular function will be 
assessed at baseline and the end of each 6 week treatment period by: 1) ultrasound guided flow-
mediated dilation (FMD) of the brachial artery, 2) impedence cardiography, 3) pulse-wave velocity, 4) 


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24 hour ambulatory blood pressure monitoring, and 5) serum and urine biomarkers.  Participants 
will undergo a total of 7 visits over 16-18 weeks; 3 of the 7 visits will involve vascular function testing.  
Pulse-wave velocity is measured non-invasively with placement of a small sensor (tonometry 
probe) over the carotid and femoral artery.  This procedure poses no discomfort and is usually done 
in about 15 minutes.  Impedence cardiography is also noninvasive with minimal inconvenience to the 
participant.  It is performed by placing small electrode pads on the chest wall and neck and takes 
about 12 minutes.  FMD is measured by assessing the change in brachial artery diameter by 
ultrasound.  A blood pressure cuff is placed below the elbow and inflated above systolic blood 
pressure for 5 minutes.  The cuff is then released and change in brachial artery is determined 
immediately afterwards for 2 minutes.  The entire procedure takes about 45 minutes.  Some back 
discomfort can occur with FMD testing as participants must lie flat for 30 minutes.  Hand and arm 
discomfort from cuff inflation is common yet resolves immediately after cuff deflation.  Collection of 
urine for 24 hours and wearing a blood pressure monitor for 24 hours can be disruptive to normal 
daily/nightly activities; however poses no danger or long-term inconvenience. 
A study visit where vascular function testing is to be performed will begin at 0800 in the morning 
and start with a vital sign assessment including height, weight, body fat percent, and left arm 
automated BP measurement followed by confirmation of fasting status and a brief past medical 
history.  Each participant will then lie supine for 10 minutes in preparation for vascular function 
testing.  Following the pulse wave velocity, impedence cardiography, and FMD measurements, the 
participant will have his/her blood and urine collected for laboratory testing.  Laboratory testing will 
include ~20 mL of blood for plasma and serum testing.  Participants will return 24 hour urine 
samples and have a 24 hour ambulatory monitor placed.  This entire visit is expected to take 2 hours.   
Study visits where vascular function testing will not be performed (e.g., screening visit, visit 2, visit 
4, and visit 5; see Table 2) should last 30 minutes and involve a medication assessment, vital sign 
check, and blood collection for serum potassium (~4 mL). 
All study medication will be prepared by the UAB Research Pharmacy in matching capsules.  .  
The order of medication dispensing will follow simple randomization using an a priori randomization 
list prepared by the research pharmacy. 
 
 
 
b. What is the probable length of time required for the entire study (i.e., recruitment 
through data analysis to study closure)? 
5 years 
c. What is the total amount of time each participant will be involved? 
16 weeks 
 


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d. If different phases are involved, what is the duration of each phase in which the 
participants will be involved? If no phases are involved, enter "not applicable." 
The cross-over design consists of two 6 week intervention periods separated by a one month 
washout period. 
 
e. List the procedures, the length of time each will take, and the frequency of 
repetition, and indicate whether each is done solely for research or would already 
be performed for treatment or diagnostic purposes (routine care) for the 
population. Insert additional table rows as needed.  
 
 
 
All procedures will be for research purposes.  Study visits 1, 3, and 6 will be approximately 120 
minutes in length.  Study visits 2, 4, and 5 will be approximately 30 minutes in length.    
 
f.  Will an interview script or questionnaire be used?  
Yes 
No 
 
If Yes, attach a copy.  
 
g. Will participants incur any costs as a result of their participation?  
Yes 
No 
If Yes, describe the reason for and amount of each foreseeable cost. 
      
 
h.  Will participants be compensated?  
Yes 
No 
If Yes, complete i-v:  
i. Type: (e.g., cash, check, gift card, merchandise): Check  
ii. Amount or Value: $100 for the study visits 1, 3, and 6 and $50 for study visits 2, 4, 5, 
screening visit, and unscheduled visit(s). 
iii. Method (e.g., mail, at visit): Mail 
iv. Timing of Payments: (e.g., every visit, each month): After the visit 
v. Maximum Amount of Payments per Participant: $500 (not including any unscheduled 
visits) 
Table 2. Combined study procedure schedule 
 
Screen Visit 
Week -(1-2) 
Visit 1 
Week 0 
Visit 2 
Week 2 
Visit 3 
Week 6 
Visit 4 
Week 10 
Visit 5 
Week 12 
Visit 6 
Week 16 
Informed consent 
X 
 
 
 
 
 
 
Study medication pill count 
 
 
X 
X 
 
X 
X 
Con medication assessment 
 
X 
 
X 
X 
 
X 
Dispense study medication 
 
X 
 
 
X 
 
 
Clinic vital signs 
X 
X 
X 
X 
X 
X 
X 
FMD 
 
X 
 
X 
 
 
X 
ACR 
X 
X 
 
X 
 
 
X 
RFP  
X 
 
 
X 
 
 
X 
24 hour ABPM 
 
X 
 
X 
 
 
X 
Plasma aldosterone, PRA 
 
X 
 
X 
 
 
X 
Blood & urine biomarkers* 
 
X 
 
X 
 
 
X 
Serum potassium via BMP 
 
 
X 
 
X 
X 
 
24hr urine collection 
 
X 
 
X 
 
 
X 
Urine Pregnancy Test 
X 
 
 
 
 
 
 
Con = concomitant, FMD = flow-mediated dilation, ACR = spot urinary albumin-to-creatinine ratio, RFP = renal function 
panel, PRA = plasma renin activity, BMP = basic metabolic panel, ABPM = ambulatory blood pressure monitor 
*Biomarkers include serum high-sensitivity C-reactive protein (hsCRP), serum pentraxin-3 (PTX-3), serum fetuin-A, 
serum uric acid, plasma asymmetric dimethylarginine (ADMA), serum soluable vascular cell adhesion molecule 
(sVCAM-1), homeostasis model assessment method of insulin resistance (HOMA-IR), plasma and urine F2-
isoprostanes, and plasma endothelin. 


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17. Describe the potential benefits of the research.  
There is no anticipated direct benefit which the participants will obtain from participating in the 
protocol.  However, indirect benefits may include discovering that spironolactone or amiloride 
reduces albuminuria and/or blood pressure.  In addition, participants who experience an 
improvement in endothelial function with spironolactone use would be expected to have a lower 
cardiovascular risk with continued use.  We feel the risks involved with participating in this study 
are reasonable in relation to the potential benefits. 
 
18. Risks  
a. List the known risks—physical, psychological, social, economic, and/or legal—that 
participants may encounter as a result of procedures required in this protocol. Do 
not list risks resulting from standard-of-care procedures. Note. Risks included in 
this protocol document should be included in the written consent document.  
No undue hazards (physical, psychological, financial, legal, or other) are anticipated with vascular 
function testing or blood and urine sampling. Participants may be exposed to several potential 
risks as itemized below: 
1. Hyperkalemia: Administration of both spironolactone and amiloride are associated with 
increases in serum potassium of approximately 0.4 mEq/L.  Serum levels of potassium will 
be monitored at each study visit.  Kayexalate and a low potassium diet will be administered 
for levels of serum potassium > 5.5 meq/L followed by a repeat potassium level in 3 days.  
Participants will be withdrawn from the study with serum potassium levels > 6.0 meq/L.  In 
addition, participants will not be allowed to participate in the second treatment period with 
a serum potassium > 5.0 meq/L when checked at week 10.   
2. Fetal toxicity: Spironolactone is associated with fetal toxicity.  Pregnant women, as 
determined by a screening urine sample, are excluded from study participation.  Women of 
child bearing potential will be advised of the risk of fetal toxicity, and if a pregnancy occurs 
during the study the participant will be withdrawn and study medication stopped. 
3. Gynecomastia: Spironolactone is associated with breast growth in men.  This association 
occurs more frequently with the long-term use of doses exceeding 50mg/day. 
4. Discomfort and risks (hematoma/skin infection) associated venous blood collection 
5. Measurement of pulse wave velocity and performing impedence cardiography is non-
invasive and entails no risk. However, measurement of FMD requires that the subject be 
supine for 30 minutes, and inflation of the blood pressure cuff for 5 minutes may cause 
discomfort.  
 
b. Estimate the frequency, severity, and reversibility of each risk listed. 
1. Hyperkalemia, defined as a serum potassium concentration > 5.5 mEq/L, is expected to 
occur in less than 5% of study participants.  Serum potassium levels will be monitored 
within 2 weeks of starting either spironolactone or amiloride in order to prevent severe or 
prolonged hyperkalemia. Rises in serum potassium levels discovered in the first 2 weeks of 
the intervention are expected to resolve within 1-2 days of stopping the medication. 
2. Fetal toxicity is not expected to occur during the study.  Pregnant women, as determined by 
a screening urine sample, are excluded from study participation.  If a pregnancy occurs 
during the study, the participant will be withdrawn and study medication stopped. 
3. Discomfort and bruising is expected to occur in the majority of venous blood collections.  
However these complications of blood collection are mild.  A skin infection due to blood 
collection is not expected to occur as standard collection techniques involving sterile 
materials and alcohol preparation will be employed. 


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4. Back discomfort from lying supine for 30 minutes for FMD measurement is expected to 
occur in less than 25% of study participants.  Lumbar support pillows are available if 
needed.  Hand and arm discomfort from blood pressure cuff inflation for 5 minutes 
commonly occurs with FMD measurement, yet completely resolves with cuff deflation.  
 
c. Is this a therapeutic study or intervention?  
Yes 
No 
 
If Yes, complete the following items: 
i. Describe the standard of care in the setting where the research will be 
conducted: The standard of care for non-diabetic patients with moderate (stage III) CKD is 
control of blood pressure and avoidance of nephrotoxic agents (e.g., nonsteroidal anti-
inflammatory and illicit drugs).  Patients with severely, uncontrolled blood pressure (e.g., 
>160/100 mm Hg) will be excluded from participation.  
 
ii. Describe any other alternative treatments or interventions: An angiotensin 
converting enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB) is 
recommended for patients who have CKD and moderate levels of albuminuria and/or 
uncontrolled hypertension.  Participation in this clinical trial will not interfere with this 
therapy.  
 
iii. Describe any withholding of, delay in, or washout period for standard of care or 
alternative treatment that participants may be currently using: Patients taking 
spironolactone, amiloride, or triamterene at baseline will be offered to hold this medication for 
1 month prior to starting the study.  All participants will undergo a 1 month washout between 
the 2 intervention periods. 
 
 
d. Do you foresee that participants might need additional medical or psychological 
resources as a result of the research procedures/interventions?  
Yes 
No 
If Yes, describe the provisions that have been made to make these resources 
available.   
      
 
e. Do the benefits or knowledge to be gained outweigh the risks to participants?  
 
 
Yes 
No 
If No, provide justification for performing the research:      
 
19. Precautions/Minimization of Risks (If study involves drugs or devices 
complete the Drug or Device Review Sheet and skip to question #20) 
a. Describe precautions that will be taken to avoid risks and the means for monitoring 
to detect risks.  
 
 
b. If hazards to an individual participant occur, describe (i) the criteria that will be 
used to decide whether that participant should be removed from the study; (ii) the 
procedure for removing such participants when necessary to protect their rights 
and welfare; and (iii) any special procedures, precautions, or follow-up that will be 
used to ensure the safety of other currently enrolled participants.  
 
c. If hazards occur that might make the risks of participation outweigh the benefits 
for all participants, describe (i) the criteria that will be used to stop or end the 
entire study and (ii) any special procedures, precautions, or follow-up that will be 
used to ensure the safety of currently enrolled participants.  
 


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20. Informed Consent 
a. Do you plan to obtain informed consent for this protocol?  
Yes 
No 
If Yes, complete the items below. 
If No, complete and include the Waiver of Informed Consent or Waiver of 
Authorization and Informed Consent, as applicable.  
 
b. Do you plan to document informed consent for this protocol?  
Yes 
No 
If Yes, complete the items below. 
If No, complete the items below and include the Waiver of Informed Consent 
Documentation.  
 
c. How will consent be obtained? Informed consent will be obtained by the PI or designated 
study personnel after reviewing the protocol, including risks, in person with the potential participant.  
Designated study personnel include Eric Judd (PI), Cassidy Clevenger (study coordinator), 
Mohammed Siddiqui (sub-investigator). 
 
d. Who will conduct the consent interview? PI or designated study personnel. 
 
e. Who are the persons who will provide consent or permission? Patients identified in a 
hypertension database from Dr. David Calhoun’s Hypertension Clinic and a CKD database from 
Dr. Dana Rizk’s CKD Clinic at the Kirklin Clinic, Dr. Eric Judd’s Kirklin Clinic, Dr. Eric Judd’s 
Cooper Green renal clinic, in the 12b2 database, or patients responding to posted flyers.   
 
f. What steps will be taken to minimize the possibility of coercion or undue influence? 
Potential participants will be informed that they are under no obligation to participate and it will 
in no way affect their routine care if they elect not to enroll.   
 
g. What language will the prospective participant or the legally authorized 
representative understand? English 
 
h. What language will be used to obtain consent? English 
 
i. If any potential participants will be, or will have been, in a stressful, painful, or 
drugged condition before or during the consent process, describe the precautions 
proposed to overcome the effect of the condition on the consent process. If not, 
enter "no such effect." 
No such effect. 
 
j. If any project-specific instruments will be used in the consenting process, such as 
flip charts or videos, describe the instrument(s) here, and provide a copy of each. 
If not, enter "not used." 
Not used 
 
k. How long will participants have between the time they are told about the study 
and the time they must decide whether to enroll? If not 24 hours or more, 
describe the proposed time interval and why the 24-hour minimum is neither 
feasible nor practical. Potential participants are given an indefinite amount of time to make a 
decision.  Some patients do enroll at their standard of care visits, but this is in no way obligatory. 
 
21. Procedures to Protect Privacy 
 
Describe the provisions included in the research to protect the privacy interests of 
participants (e.g., others will not overhear your conversation with potential 
participants, individuals will not be publicly identified or embarrassed). 


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All discussions with potential participants will be done in clinic rooms with the door closed so 
others will not be able to overhear the conversation.  Potential participants will in no way be 
publicly identified or embarrassed. 
 
 
22. Procedures to Maintain Confidentiality 
a. Describe the manner and method for storing research data and maintaining 
confidentiality. If data will be stored electronically anywhere other than a server 
maintained centrally by UAB, identify the departmental and all computer systems 
used to store protocol-related data, and describe how access to that data will be 
limited to those with a need to know. 
The study database will be maintained on a computer with access restricted by password 
protection to study staff.  A non-specific participant number will be generated for each participant 
(e.g., CKD1501).  The list linking the participant numbers to the participant identifiers will kept in 
a secure location with password-protection, and only the PI and designated study personnel will 
have access to this list.  Data will be stored with use of the participant numbers without 
identifiable labels such as names, medical record number or social security number. 
  
b. Will any information derived from this study be given to any person, including the 
subject, or any group, including coordinating centers and sponsors?  
Yes 
No  
 
If Yes, complete i-iii. 
 
i. To whom will the information be given? UAB IRB 
 
ii. What is the nature of the information? Summary data without individual personal 
identifiers 
 
iii. How will the information be identified, coded, etc.? Information will only be 
presented as summarized data without individualized information. 
 
23. Additional Information 
In the space below, provide any additional information that you believe may help 
the IRB review the proposed research, or enter "None."  
None