A Post-Market, Single Blind, Randomized Clinical Prospective Study on Intradialytic Symptoms in Subjects Treated With Qd 500vs Qd 300
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Sponsor: Outset Medical

Outset Medical 
 
CONFIDENTIAL 
 
Page 1 of 13 
Study# 2019-03 
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Confidential and Proprietary 
Nothing herein is to be disclosed without the expressed written consent of Outset Medical. 
 
Study # 2019-03 
 
Study Title:  A Post-Market, Single Blind, Randomized Clinical Prospective Study on Intradialytic Symptoms in 
Subjects treated with Qd 500vs Qd 300 
 
 
Study Dates: 
 
 
 
September 2019 to December 2019 
 
Principal Investigator:  
 
Dr. George Coritsidis, MD 
 
Sponsor Contact Information:  
Michael Aragon, MD, CMO,  
Outset Medical 
San Jose, CA 95112, USA 
 
 
GCP Compliance: 
Investigators agreed to conduct the investigation in 
accordance with applicable FDA regulations, ISO 14155:2011, 
ICH-GCP Guidelines, and in accordance with the ethical 
principles originating in the Declaration of Helsinki (64th WMA 
General Assembly, Forteleza, Brazil October 2013) and any 
conditions imposed by the reviewing Institutional Review 
Board (IRB). Investigators agreed to ensure appropriate 
informed consent was obtained from all subjects prior to 
inclusion. 
The study is conducted in accordance with the study protocol, 
relevant Good Clinical Practice (GCP), and International 
Conference on Harmonization (ICH) guidelines, as well as in 
conjunction with 21 CFR Part 812, 50, 54, 56 and other 
applicable government regulations. 
 
 
 

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Table of Contents 
1 
PROTOCOL SYNOPSIS ..................................................................................................................3 
2 
ABBREVIATIONS ..........................................................................................................................4 
3 
BACKGROUND .............................................................................................................................4 
4 
STUDY OBJECTIVE ........................................................................................................................5 
5 
STATEMENT OF COMPLIANCE ......................................................................................................5 
6 
STUDY DESIGN ............................................................................................................................5 
6.1 
Effort to Minimize Bias ................................................................................................................... 5 
6.2 
Evaluation of Safety ........................................................................................................................ 6 
6.3 
Blinding and Randomization ........................................................................................................... 6 
7 
SUBJECT SELECTION.....................................................................................................................6 
7.1 
Study Population ............................................................................................................................ 6 
7.2 
Informed Consent ........................................................................................................................... 6 
7.3 
Subject Privacy................................................................................................................................ 6 
7.4 
Inclusion Criteria ............................................................................................................................. 7 
7.5 
Exclusion Criteria ............................................................................................................................ 7 
7.6 
Subject Discontinuation and Replacement .................................................................................... 7 
8 
STUDY PROCEDURES AND DATA COLLECTION ..............................................................................8 
8.1 
Baseline Evaluation......................................................................................................................... 8 
8.2 
Group 1 ........................................................................................................................................... 8 
8.3 
Group 2 ........................................................................................................................................... 8 
9 
STUDY LIMITATIONS ....................................................................................................................8 
10 
ETHICAL CONSIDERATIONS .......................................................................................................8 
11 
STATISTICAL METHODS ............................................................................................................9 
12 
STUDY RECORD MANAGEMENT ................................................................................................9 
13 
TRAINING ................................................................................................................................9 
14 
QUALITY CONTROL AND ASSURANCE .......................................................................................9 
14.1 
Selection of Sites and Investigators ............................................................................................ 9 
14.2 
Institutional Review Board Protocol and Informed Consent Approvals ..................................... 9 
14.3 
Privacy and Confidentiality ....................................................................................................... 10 
15 
REFERENCES .......................................................................................................................... 10 
APPENDIX A: SCHEDULE OF ASSESSMENTS ....................................................................................... 12 
 

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1 
PROTOCOL SYNOPSIS 
Title 
A Post-Market, Single Blind, Randomized Clinical Prospective Study on Intradialytic 
Symptoms in Subjects treated with Qd 500 vs Qd 300 
Study Goal 
To determine the impact of dialysate flow rate (Qd) on Subject reported dialysis related 
symptoms and on time to recovery post dialysis. 
Study Background 
Subjects undergoing conventional intermittent thrice weekly hemodialysis using a Qd of 
500ml/min or higher report many inter and intra dialytic symptoms. Common symptoms 
include fatigue, cramping, and insomnia.  
Subjects treated on the Tablo hemodialysis system  report ‘feeling better’. Tablo has a 
dialysate flow rate of 300 ml/min. 
Study Objective 
The objective of this study is to determine if Subjects who report dialysis symptoms while 
meeting adequacy (as determined by Kt/V of 1.2 or greater) on thrice weekly dialysis or 
who have a recovery time of at least 4 hours when treated on a conventional, i.e. non 
Tablo, hemodialysis device feel better with a reduced dialysate flow rate of 300ml/min 
based on an assessment of time to recovery post dialysis and Subject reported symptoms 
via a modified weekly ESAS survey. 
Study Length 
The study will last approximately 8 weeks consisting of chart review, Subject selection, 
medical record review, data collection and data analysis.  
Inclusion Criteria 
1. 
Subject has provided informed consent and has signed a Health Insurance Portability 
and Accountability Act of 1996 (HIPAA) compliant authorization statement.  
2. 
Subject is at least 18 of age. 
3. 
Subject has end stage renal disease (ESRD) adequately treated with thrice weekly 
dialysis. 
4. 
Subject is currently stable on dialysis for at least 3 months on a conventional dialysis 
machine and Qd of 500ml/min or higher with no change in the following dialysis 
prescription parameters over that time: Qb, Qd, Dialyzer, Time. 
5. 
Subject has a baseline Kt/V of greater than 1.2. 
6. 
Subject has a stable vascular access. 
7. 
Subject reports time to recovery of more than 4 hours or a modified ESAS with at least 
5 symptoms of which at least 2 are rated as moderate (rating of 4-6) or severe (rating 
of 7-10). 
Exclusion Criteria 
1. 
Subject is unable to complete the questionnaires. 
2. 
Subject is pregnant or planning to become pregnant. 
3. 
Subject is scheduled for a change in modality or expected kidney transplant in the next 
3 months. 
4. 
Any other documented condition that the Investigator feels would prevent the Subject 
from successful inclusion in the study. 
Primary Endpoint 
 Change in time to recovery and self-reported symptoms. 
Secondary Endpoint 
Caregiver assessment of changes in Subject’s health, missed or reduced treatments, 
number of intradialytic interventions ( saline, prn medications, early discontinuation, UF 
change related to sxs) and the reason for intervention. 

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2 
ABBREVIATIONS 
BUN 
Blood Urea Nitrogen 
CBC 
Complete Blood Count 
CFR 
Code of Federal Regulations 
CO2 
Carbon Dioxide 
QD 
Dialysate Flow Rate 
QB 
Blood Flow Rate  
ESRD 
End Stage Renal Disease 
ESAS 
Modified Edmonton Symptoms Assessment System 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HRQoL 
Health Related Quality of Life 
ICH 
International Conference on Harmonization 
KDQoL 
Kidney Disease Quality of Life Survey 
PHOS 
Phosphorus 
IRB 
Institutional Review Board 
K 
Potassium 
Na 
Sodium 
PI 
Principle Investigator 
TTR 
Time to Recovery  
UF 
Ultrafiltration, volume of fluid removed 
 
3 
BACKGROUND 
Subjects experience various symptoms during hemodialysis. Prior studies have shown that fatigue, muscle cramps, 
insomnia and pruritis are most commonly reported as symptoms associated with dialysis(5).. The frequency and 
severity of intradialytic symptoms are associated with missed treatments, shortened treatment time and delayed 
time to recovery after dialysis (3,7,8).. Longer time to recovery has also been shown to be a simple, reproducible, 
tool associated with poorer HRQoL, hospitalization and mortality (3,4). Subjects treating on the Tablo system have 
previously reported feeling better when dialyzing thrice weekly with this device. The Tablo system utilizes a 
dialysate flow rate of 300ml/min to achieve the standard adequacy target as defined as a Kt/V of 1.2 or greater 
(1,9). To better understand the feeling better effect on Tablo, this study was designed to determine if a decrease in 
dialysate flow rate on a conventional dialysis device produces a similar effect on Subject reported symptoms. This 
study assesses time to recovery as well as prevalence and severity of Subject reported symptoms via a weekly 
modified Edmonton Symptom Assessment System when dialysate flow rate is decreased from 500ml/min or higher 

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to 300ml/min on standard thrice weekly dialysis. In addition, the Subject’s primary caregiver will be given a KDQoL 
SF-36 to complete as to their perception of the Subject’s quality of life at baseline as well as after each 4-week 
interval. These assessment tools have been shown to be reliable, simple methods for symptom assessment 
(2,4,8,10,11,12). 
4 
STUDY OBJECTIVE 
The objective of this study is to determine if Subjects who report dialysis symptoms while meeting adequacy (as 
determined by Kt/V of 1.2 or greater) on chronic thrice weekly dialysis or who have a recovery time of more than 4 
hours when treated on a conventional, i.e. non Tablo, hemodialysis device feel better with a reduced dialysate flow 
rate of 300ml/min based on an assessment of time to recovery post dialysis, weekly modified ESAS, and Subject’s 
caregiver assessment of the Subject’s symptoms. 
5 
STATEMENT OF COMPLIANCE 
This study will be conducted according to the protocol, good clinical practice (GCP) and all applicable regulatory 
requirements (21CFR). 
6 
STUDY DESIGN 
This is a single center, post market, prospective, single blind, randomized, cross-over study involving approximately 
50 subjects currently dialyzing on a conventional dialysis machinevat a dialysate flow rate of 500ml/min or higher 
thrice weekly. The study may collect retrospective and prospective medical records and other treatment data. 
Enrolled subjects will answer the question, “How long does it take you to recover from a dialysis session?” (TTR) 
along with a modified ESAS at baseline and weekly. Subjects will be screened prior to entry into the study and 
enrolled if time to recovery at baseline of > 4 hours or the results of their modified ESAS demonstrate at least 5 
dialysis related symptoms with at least 2 being described as moderate (rating of 4-6) or severe (rating of 7-10). 
Caregivers of screened Subjects meeting the study criteria will be given a baseline KDQoL SF-36 to determine their 
perception if the Subject’s current state of health. Subjects enrolled will be randomized to two groups. Group 1 will 
dialyze for the first 4 weeks of the study at a Qd of 300ml/min, then for the last 4 weeks at a Qd of 500ml/min. 
Group 2 will dialyze for the first 4 weeks of the study at a Qd of 500ml/min, then for the last 4 weeks at a Qd of 
300ml/min. At the end of each week, the Subject will respond to the TTR question as well as the modified ESAS 
survey. Subject caregivers will complete the KDQoL at the end of each 4-week interval. The study will assess the 
Subject and Subject caregiver responses to the survey tools as well as other outcome measures which may include 
but are not limited to, kinetics, laboratory values, blood pressure measurement, intradialytic interventions, missed 
or shortened treatments, and/or changes to treatment parameters. The study will collect subject demographics 
and dialysis related medications. The goal is to enroll at least 15 Subjects who report intradialytic symptoms as the 
ITT group for study analysis. 
6.1 
Effort to Minimize Bias 
All eligible Subjects that, in the treating physician’s best medical judgement, meet the selection criteria will be 
asked to participate in this study. Subjects will not be excluded based on gender, race, ethnicity or sexual 
orientation. 

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6.2 
Evaluation of Safety 
Treatment with a Qd of 300ml/min has been shown to be safe and effective in the treatment of ESRD subjects. It 
has also been demonstrated that dialysis at a Qd of 300ml/min can achieve the prescribed adequacy target of  a 
Kt/v of 1.2 or greater. Standard safety precautions as per clinic protocol will be continued. No portion of this study 
will be beyond the standard of care. 
6.3 
Blinding and Randomization 
This study is a single center, post market, prospective, single blind, randomized, cross-over study comparing 
symptoms with a conventional dialysis device at a Qd of 500 ml/min and a Qd of 300 ml/min. Only Subjects will be 
blinded to the dialysis device Qd.  
Subjects will be randomized to either arm at a 1:1 ratio using excel’s RANDBETWEEN function. Subjects will be 
randomly assigned a 0 or a 1. Subjects that are assigned ‘0’ will go to Group 1, and subjects that are assigned ‘1’ 
will go to Group 2. 
7 
SUBJECT SELECTION 
7.1 
Study Population 
Subjects with a diagnosis of end stage renal disease (ESRD) who meet the inclusion and exclusion criteria will be 
eligible for participation in this study.  Subjects with all vascular access types are eligible for the study and may 
include catheters, grafts, and fistulas.  Potential study candidates should be screened for eligibility according to the 
study inclusion and exclusion criteria.   
7.2 
Informed Consent 
IMPORTANT:  The Code of Federal Regulations requires that the consent form signed by the Subject must be 
dated at the time consent is given.  Also, medical records must contain documentation that informed consent 
was obtained prior to participation in a study.  (21 CFR Parts 50 and 812) 
The Investigator may determine whether potential Subjects are interested in participating in an investigation, but 
shall not request the written informed consent of any Subject to participate, and shall not allow any Subject to 
participate before obtaining Institutional Review Board (IRB) and FDA approval.  The consent process shall begin 
before care is altered beyond the scope of a routine comprehensive examination for the purpose of participating 
in this study. 
All Subjects in this research study should be completely informed about the purpose, duration, and pertinent 
details of the study.  The informed consent process must be documented using a written form that has been 
approved by the IRB and includes all Basic Elements of Informed Consent and pertinent Additional Elements (21 
CFR Part 50.25).   
The Investigator must keep the original signed copies of all consent forms in the Subject’s medical records and 
provide a copy to each Subject. 
Appendix A outlines the screening and enrollment process and illustrates the point where informed consent 
should be obtained. 
7.3 
Subject Privacy 
In accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), all Subjects should be 
informed of potential uses and disclosures of their medical information for research purposes, and their rights to 
access information about them by covered entities.  Each Investigator will follow the procedures for securing 
HIPAA compliance as directed by their respective IRB or Privacy Board, and to obtain written authorization to use 
and disclose Subject information for all clinical research and research involving questioning of the Subject’s or 

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Subjects’ physician(s).  Per individual site procedures, this authorization may be included as part of the Subject 
informed consent form. 
7.4 
Inclusion Criteria  
Subjects must meet ALL of the inclusion criteria to be enrolled in the study. 
1. Subject has provided informed consent and has signed a Health Insurance Portability and Accountability 
Act of 1996 (HIPAA) compliant authorization statement.  
2. Subject is at least 18 of age. 
3. Subject has end stage renal disease (ESRD) adequately treated with thrice weekly dialysis. 
4. Subject is currently stable on dialysis for at least 3months on an FMC 2008K machine and Qd of 
500ml/min or higher with no change in the following dialysis prescription parameters over that time: Qb, 
Qd, Dialyzer, Time. 
5. Subject has a baseline Kt/V of greater than 1.2. 
6. Subject has a stable vascular access. 
7. Subject reports time to recovery of more than 4 hours or a modified ESAS with at least 5 symptoms of 
which at least 2 are rated as moderate (rating of 4-6) or severe (rating of 7-10). 
7.5 
Exclusion Criteria  
If ANY of the exclusion criteria are met, the Subject is excluded from the study. 
1. Subject is unable to complete the questionnaires. 
2. Subject is pregnant or planning to become pregnant 
3. Subject is scheduled for a change in modality or expected kidney transplant in the next 3 months. 
4. Any other documented condition that the Investigator feels would prevent the Subject from successful 
inclusion in the study. 
7.6 
Subject Discontinuation and Replacement 
Every Subject should remain in the study until completion of the required follow-up period.  Subjects may 
voluntarily withdraw from the study at any time with or without reason and it will not have any negative impact on 
subsequent treatment. Conceivable reasons for Subject discontinuation may include, but are not limited to, the 
following: 
 
Subject Withdrawal: Subject participation in this study is voluntary.  The Subject may choose to 
discontinue participation at any time without loss of benefits or penalty.  
 
Discontinuation:  Subject participation may be discontinued by the Subject or Investigator because of a 
kidney Transplantation, relocation to another dialysis center, treatment modality change, hospitalization 
or death. 
 
Sponsor/Investigator Termination: The Sponsor/ Investigator may terminate the Subject’s participation 
without regard to the Subject’s consent if the Sponsor/Investigator believes it is necessary. 
 
 
Exclusion Criterion Discovered After Enrollment: A small number of Subjects may be enrolled despite 
meeting an exclusion criteria due to timing of study required clinical procedures. This will be documented 
by the study personnel and will be considered a protocol deviation.  

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8 
STUDY PROCEDURES AND DATA COLLECTION 
8.1 
Baseline Evaluation  
Subjects will be asked for their response to the TTR question and a modified ESAS. Subjects meeting the inclusion 
and exclusion criteria, will be consented and enrolled into the study. Enrollees will be randomized to treatment 
Group 1 or 2. Enrollee caregivers will be asked to complete a KDQoL SF-36 regarding their perception of the 
Subject’s overall health. Additionally, historical dialysis treatment information including hemodialysis prescription 
and any recent changes, baseline laboratory values including kinetics, temperature, height, weight, body mass 
index, vascular access type, presence or absence of diabetes mellitus, hypotension, ejection fraction, arrhythmia, 
high blood pressure, and any other co-morbid conditions considered relevant may also be collected where 
available. Any subjects of child-bearing potential will be given a pregnancy test to confirm negative results. Those 
subjects will also be utilizing medically acceptable means of contraception during the study period. Demographic 
information will be collected including age, gender, ethnicity and race. Dialysis related medications, laboratory 
values, blood pressure readings taken before, during and after dialysis treatments and adverse event data may 
also be collected if available.  
8.2 
Group 1 
Subjects will undergo staff administered dialysis treatment 3 times/week for 8 weeks In-Center with prescription 
adjustments as outlined in the Schedule of Events. Subjects will respond to the TTR question and modified ESAS at 
the completion of every week. Caregivers will be asked to respond to the KDQoL SF-36 during week 4 and week 8. 
Subjects Serum Potassium, BUN, CO2, Phos, Na, Beta-2-Microglobulin, Vitamin B12and Kt/V labs  and treatment 
flowsheets will also be evaluated. Dialysis prescription changes, dialysis related medications, blood pressure 
readings taken before, during and after dialysis treatments and adverse event data may also be collected if 
available. Group 1 will dialyze for the first 4 weeks of the study at a Qd of 300ml/min, then for the last 4 weeks at a 
Qd of 500ml/min. 
8.3 
Group 2  
Subjects will undergo staff administered dialysis treatment 3 times/week for 8 weeks In-Center with prescription 
adjustment as outlined in the Schedule of Events. Subjects will respond to the TTR question and modified ESAS at 
the completion of every week. Caregivers will be asked to respond to the KDQoL SF-36 during week 4 and week 8. 
Subjects Serum Potassium, BUN, CO2, Phos, Na, Beta-2-Microglobulin, Vitamin B12 and Kt/V labs and treatment 
flowsheets will also be evaluated. Dialysis prescription changes, dialysis related medications, blood pressure 
readings taken before, during and after dialysis treatments and adverse event data may also be collected if 
available. Group 2 will dialyze for the first 4 weeks of the study at a Qd of 500ml/min, then for the last 4 weeks at a 
Qd of 300ml/min. 
9 
STUDY LIMITATIONS 
Limitation of this include its small size and in a single center. Additionally, every attempt has been made to remove 
any variables other than change in dialysis treatment device; however, Subjects with ESRD have complex medical 
histories and the effect of illness unrelated to ESRD (whether worsened or improved) was not taken into 
consideration. Socioeconomic factors that can affect a Subject’s sense of wellbeing or any changes to these factors 
during the study were also not accounted for.  
10 
ETHICAL CONSIDERATIONS 
Risks: The risks to subjects participating in this study are minimal. Subjects will be informed of the potential risk of 
an overall decrease in weekly Kt/V due the change in Qd. A possible risk is exposure of protected health 
information. Every effort will be made to maintain subject privacy. 
Benefits: The study will provide information on Subject self-reported symptoms in the real world setting for 
subjects who dialyze thrice weekly with a dialysate flow rate of 500ml/min who are changed to a dialysate flow 

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rate of 300ml/min. Pts will be informed of the potential benefits from none to possible reduction in symptoms 
from the potential intervention. Subjects and their caregivers will be compensated for their time and effort to 
complete the surveys as requested.  
Participation in this study is voluntary. Failure to participate in the study will not impact Subject care. 
11 
STATISTICAL METHODS 
Descriptive statistics will be performed. Data resulting from this study may be compared to prior studies evaluating 
the frequency of Subject reported symptoms. 
12 
STUDY RECORD MANAGEMENT 
Trained personnel at the site, as directed by the principle investigator (PI), will collect data in accordance with this 
protocol and ensure that it is appropriately recorded on paper worksheets and case report forms and/or in an 
electronic data capture system.  
The Investigator agrees to maintain all essential study documents and source documentation, in original format, 
that support the data collected on the study subjects in compliance with the ICH/GCP guidelines (the Investigator’s 
File, including signed informed consent forms (ICF) and subject-related materials) in a location that is secure and to 
which access can be gained if required.  
Documents must be retained for at least two years after (1) study completion, or (2) the study has been 
terminated by the Sponsor. These documents will be retained for a longer period of time by agreement with the 
Sponsor or in compliance with other regulatory requirements. When these documents no longer need to be 
maintained, it is the study Sponsor’s responsibility to inform the Investigator. The Investigator will take measures 
to ensure that these essential documents are not accidentally damaged or destroyed. If, for any reason, the 
Investigator withdraws responsibility for maintaining these essential documents, custody must be transferred to 
an individual who will assume responsibility. The Sponsor must receive written notification of this custodial 
change. 
13 
TRAINING 
Prior to opening the study and enrolling Subjects, the PI and all participating study personnel will be trained on the 
study requirements. Initial training and any needed follow-up training will be documented in the appropriate 
regulatory binders. 
14 
QUALITY CONTROL AND ASSURANCE 
14.1 
Selection of Sites and Investigators 
The Sponsor will select the Investigators who are qualified by training and experience to perform the procedures 
as required per this protocol and to participate in this investigation. A site selection process will be followed, 
including a qualification visit to the institution as necessary. In order to participate in the clinical study, the 
Investigator must be in good standing, provide a current Curriculum Vitae to validate his/her experience and a 
current copy of his/her medical license.  
14.2 
Institutional Review Board Protocol and Informed Consent Approvals 
A sample Informed Consent form (ICF) will be provided for the study Investigator(s) to prepare for use at his/her 
site prior to participation in the study. The written Informed Consent documents should be prepared in the 
language(s) of the potential Subject population. The ICFs that are used should be in accordance with the current 
guidelines as outlined by the 21CFR Part 50, Good Clinical Practices (GCP) guidelines and the International 
Conference on Harmonization (ICH). 

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The study Sponsor and reviewing IRB must first approve the language and the content within the Informed 
Consent form that is to be used by each study site. A copy of the proposed Informed Consent form, other written 
Subject information and any proposed advertising material must be submitted to the IRB for written approval. A 
copy of the written IRB approval of the protocol and Informed Consent form must be received by the study 
Sponsor before recruitment and enrollment of Subjects into the study. The written approval must identify the 
study, protocol version, and the date of approval. The Investigational site must submit to and, where necessary, 
obtain approval from, the IRB for all subsequent protocol amendments and changes to the Informed Consent Form 
prior to implementation.  
The Investigator will be responsible for obtaining annual IRB approval and renewal throughout the duration of the 
study. The Investigator and site personnel must forward copies to the Sponsor of all required correspondence with 
the IRB, including the annual and continuing review reports and IRB continuance of approval.  Copies of such 
correspondence should be filed in the Investigational site study files. Additionally, the Investigator will provide an 
IRB membership list or assurance number to the Sponsor annually. 
14.3 
Privacy and Confidentiality 
In accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), all subjects will be 
informed of potential uses and disclosures of their medical information for research purposes, and their rights to 
access information about them by covered entities. Each Investigator will follow the procedures for securing HIPAA 
compliance as directed by their respective IRB or Privacy Board, and to obtain written authorization to use and 
disclose subject information for all clinical research and research involving questioning of the subject’s or subjects’ 
physician(s). Per individual site procedures, this authorization may be included as part of the ICF.  
All information and data sent to Outset, and its authorized representatives, concerning subjects or their 
participation in this study will be considered confidential. All data used in the analysis and reporting of this 
evaluation will be used in a manner without identifiable reference to the subject.  
The Investigator will ensure that this study is conducted in full conformity with the current revision of the 
regulations and guidelines of FDA (21 CFR Part, 50, 54 and 56, and the relevant parts of the ICH Guidelines for 
Good Clinical Practice).  
Information from this study may be used in publications, presentations, abstracts, and advertising but will not 
reveal any personal identifying information for any study subject. 
 
15 
REFERENCES 
1.Leypoldt, K, Prichard S2, Chertow GM3, Alvarez L4. Differential Molecular Modeling Predictions of Mid and 
Conventional Dialysate Flows. Blood Purification 2019 Jan 30:1-8.  
2.Davison SN, Jhangri GS, Johnson JA. Cross-sectional validity of a modified Edmonton symptoms assessment 
system in dialysis patients: A simple assessment of symptom burden. Kidney Int. 2006;69,1621-1625 
3.Mapes DL, Lopes AA, Satayathum S, et al. Health-related quality of life as a predictor of mortality and 
hospitalization: The Dialysis Outcomes and Practice Patterns Study (DOPPS) Kidney Int. 2003;64:339–349.  
4.Lindsay RM, Heidenheim PA, Nesrallah G, Garg AX, Suri R. Minutes to Recovery after a Hemodialysis Session: A 
Simple Health-Related Quality of Life Question That Is Reliable, Valid, and Sensitive to change. Clin J Am Soc 
Nephrol. 2006;1(5):952–959. 
5.Flythe, JE, et al. Patient-Reported Outcome Instruments for Physical Symptoms Among Patients Receiving 
Maintenance Dialysis:A Systematic Review. Am J Kidney Dis. 2015;66(6):1033-1046  
6.Flythe JE, Assimon MM, Wenger JB, Wang L: Ultrafiltration Rates and the Quality Incentive Program: Proposed 
Measure Definitions and Their Potential Dialysis Facility Implications. Clin J Am Soc Nephrol. 2016;11(8):1422-33 

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7.Dimitri Augustin, MD et al. In-vivo Dialysis Kinetics of 300 ml/min and 500 ml/min Dialysate Flows. In: American 
Society of Nephrology Kidney Week Oct. 23-28. San Diego California. ASN; 2018. 
8.Hugh C. Rayner, Lindsay Zepel, Douglas S. Fuller et al. Recovery Time, Quality of Life, and Mortality in 
Hemodialysis Patients: The Dialysis Outcomes and Practice Patterns Study (DOPPS) Am J Kidney Dis. 2014;64(1):86-
94  
9. Luis Alvarez MD, PhD et al. Urea Clearance Results in Patients Dialyzed Thrice Weekly Using a Dialysate Flow 
Rate of 300ml/min. In: Annual Dialysis Conference March 16-19. Dallas, TX. ADC; 2019. 
10.Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) 
instrument. Qual Life Res 3: 329-338, 1994. 
11.Aiyegbusi OL, Kyte D, Cockwell P, Marshall T, Gheorghe A,Keeley T, et al. Measurement properties of patient-
reported outcome measures (PROMs) used in adult patients with chronic kidney disease: A systematic review. 
PLoS One 12:e0179733, 2017. 
12. Ricardo AC, Hacker E, Lora CM, Ackerson L, DeSalvo KB, Go A, Kusek JW, Nessel L, Ojo A, Townsend RR, Xie D, 
Ferrans CE, Lash JP; CRIC Investigators. Validation of the Kidney Disease Quality of Life Short Form 36 (KDQOL-36) 
US Spanish and English versions in a cohort of Hispanics with chronic kidney disease.Ethn Dis. 2013 
Spring;23(2):202-9. 
 
 

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APPENDIX A: SCHEDULE OF ASSESSMENTS 
Study Schedule 
Source 
Week -1 
Week 0 
Week 1 
Week 2 
Week 3 
Week 4 
Week 5 
Week 6 
Week 7 
Week 8 
Week 9-12 
Baseline 
Chart Review for Inclusion/Exclusion Criteria 
Medical Record 
X 
  
  
  
  
  
  
  
  
  
  
Review of Dialysis Related Medications 
Medical Record 
  
X 
  
  
  
  
  
  
  
  
  
Informed Consent  
Subject 
  
X 
  
  
  
  
  
  
  
  
  
Enrollment 
Subject 
  
X 
  
  
  
  
  
  
  
  
  
Modified ESAS and TTR 
Subject 
X 
  
  
  
  
  
  
  
  
  
  
KDQoL SF-36 
Caregiver 
X 
  
  
  
  
  
  
  
  
  
  
Kt/V Assessment 
Medical Record 
  
X 
  
  
  
  
  
  
  
  
  
Serum Potassium, BUN, CO2, Phos, Na, Beta-2-
Microglobulin, Vitamin B12 
Medical Record 
  
X 
  
  
  
  
  
  
  
  
  
Trial  
  
  
  
  
  
  
  
  
  
  
  
  
Group 1 
Qd 300  
  
  
  
X 
X 
X 
X 
  
  
  
  
  
Qd 500  
  
  
  
  
  
  
  
X 
X 
X 
X 
  
Group 2 
Qd 500  
  
  
  
X 
X 
X 
X 
  
  
  
  
  
Qd 300  
  
  
  
  
  
  
  
X 
X 
X 
X 
  
Modified ESAS and TTR 
Subject 
  
  
X 
X 
X 
X 
X 
X 
X 
X 
  
KDQoL SF-36 
Caregiver 
  
  
 
  
  
X 
 
  
  
X 
  
Kt/V Assessment 
Medical Record 
  
  
X 
  
  
  
X 
  
  
  
  
Serum Potassium, BUN, CO2, Phos, Na, Beta-2-
Microglobulin, Vitamin B12 
Medical Record 
  
  
X 
  
  
  
X 
  
  
  
  
Trial Conclusion 
  
  
  
  
  
  
  
  
  
  
  
Review of Tx Records and Intradialytic 
interventions 
Flow Sheet 
  
  
  
  
  
  
  
  
  
  
X 
Review of Missed or shortened treatments 
Medical 
Record/Flow 
Sheet 
  
  
  
  
  
  
  
  
  
  
X 
Analysis of Responses to TTR, ESAS, KDQoL 
  
  
  
  
  
  
  
  
  
  
  
X 
Draft final study report 
  
  
  
  
  
  
  
  
  
  
  
X 

Outset Medical 
 
CONFIDENTIAL 
 
 
 
 
Page 13 of 13 
 
Study# 2019-03 
DOC-0004298, Rev 03