Supplementation of Thyroid Hormone for TSH Control in Patients With Chronic Kidney Disease Without Renal Replacement Therapy: Randomized, Double-blind Clinical Trial at Guadalajara Civil Hospital.
Phase: PHASE3
Conditions: Chronic Kidney Diseases, Subclinical Hypothyroidism
Sponsor: Hospital Civil de Guadalajara

 
 
 
Start of the clinical trial: Octuber 1, 2018. 
Term of the study: January 31, 2019. 
 
 
 
 
 
Study 
Identification. 
HospitalCG 
034/18 
clinical study 
 
Official Title: Supplementation of thyroid 
hormone for TSH targets in patients with 
chronic 
kidney 
disease 
without 
renal 
substitution therapy: randomized, double-
blind clinical trial at the Guadalajara Civil 
Hospital.  
 
 
 
 
 
 
 
 
 
 

 
 
1. 
Study Identification. HospitalCG 034/18 clinical study 
 
 
 
Brief Title: Supplementation of Thyroid Hormone for TSH Control in Patients With Chronic 
Kidney Disease Without TRR. (TSHrenal) .  
Acronym: TSH-renal 
Official Title: Supplementation of thyroid hormone for TSH targets in patients with 
chronic kidney disease without renal substitution therapy: randomized, double-blind 
clinical trial at the Guadalajara Civil Hospital.  
Study Type: Interventional (clinical trial). 
 
2. 
Study Status 
 
Record Verification Date: march 15, 2019  
 
Overall Recruitment Status: Completed: The study has concluded normally; 
participants are no longer receiving an intervention or being examined (that is, last 
participant’s last visit has occurred) 
 
Study Start Date: Octuber 1, 2018 
 
Primary Completion Date: January 31, 2019 
 
Study Completion Date  March 1, 2019. 
 
3.Sponsor/Collaborators 
 
Sponsor: Hospital Civil de Guadalajara 
 
Responsible 
party: 
Principal 
investigator: 
Guillermo 
Navarro 
Blackaller 
(GBLACKALLER) 
 
Official Title: Resident of nephrology 
 
Affilitaion: Hospital Civil de Guadalajara 
 
 
 
4. Oversight 
U.S. FDA-regulated Drug: no 
U.S. FDA-regulated Device: no 
U.S. FDA IND/IDE: no 
Human Subjects Review: Board Status: Approved     Approval Number: 034/18  
Board 
Name: 
Ethics 
Committee 
034/18  
Board 
Affiliation: 
Hospital 
Civil 
de 
Guadalajara 
Phone: 3336147748   Ext: 2584    
 Email: 
greenavarroblackalle@hotmail.com 
Address: Hospital #278 
Data Monitoring: no 
FDA Regulated Intervention: no 
 
5. Brief Summary: 
Study design: Phase II study, randomized, double-blind, unicentric, two-arm, placebo-
controlled clinical trial. Methods and participants: Patients with Chronic Kidney Disease 
G2-G5 with proteinuria without renal replacement therapy, who come to the clinic of renal 

health clinic of the Fray Antonio Alcalde civil hospital. As criteria for non-inclusion, need for 
dialysis, primary hypothyroidism or pre-existing thyroid disease, ischemic heart disease in 
a period less than 6 months, arrhythmia, pregnancy, use of drugs that interact with 
synthesis of thyroid hormones, do not accept informed consent, thyroid stimulating 
hormone (TSH) <2.5 uiml / L or TSH> 10 uiml / L. 
6. Detailed Description: 
Thyroid disorders, especially elevated TSH levels in patients with CKD, are frequent. As it 
is an easy medication to acquire and of little cost compared to the other options, 
levothyroxine would provide benefits already known in patients with CKD and also a 
proteinuria effect (knowing each other). as a factor of progression of the CKD a health 
problem worldwide) being a potentially useful treatment and a dose that the risk is minimal. 
The study consists of 3 phases, the first phase consists of capturing patients from the 
renal health clinic, having baseline measurement of the variables. Then, the second phase 
consists of both groups treating them with medication (levothyroxine with a safe dose for 
the investigator's population with high cardiovascular risk of 0.25mcg so that the patient's 
weight range between 50-80kg maintains a dosage of 0.3-0.5mcg / kg / day that the 
thyroid axis is not affected) of fasting levothyroxine (in the case of taking a drug that 
interacts with absorption changes its use according to the specified hours, see Table 2) or 
placebo according to the randomization 1: 1 for three months and that have treatment with 
ACEI or ARA-2 (specifying which and the dose thereof), with follow-up every 4 weeks 
(Monitoring thyroid function). The third phase consists of a comparison of the variables 
studied. 
The primary objective is to evaluate the effect of the use of levothyroxine on the levels of 
proteinuria measured on the test strip of the general urine and protein examination in 24-
hour urine patients with chronic kidney disease without renal support therapy with 
proteinuria, who already receive the standard antiproteinuric treatment with an ACE 
inhibitor or ARA-2 against placebo and the secondary objectives are to evaluate the 
changes in proteinuria, according to TSH levels in 2.5-9.9 μiml /L, with the levels of T4L in 
levels 0.8-1.8mcg / ml), analyze improvement in glomerular filtration rate in patients 
receiving levothyroxine and at the end of the study and evaluate Tolerability and safety of 
levothyroxine as antiproteinuric treatment in chronic kidney disease without renal support 
therapy, and as secondary objectives improvement in cholesterol, triglycerides blood 
pressure. Any adverse event will be recorded in the adverse event reporting forms. 
(definition of the International Conference on Harmonization [ICH]) 
 
 
 
 
 
 
 
 

 
 
 
Study Type: 
Interventional 
Actual Enrollment: 
32 participants 
Allocation: 
Randomized 
Intervention Model: 
Parallel Assignment 
Phase II study, type placebo controlled clinical trial, randomized of 
two arms, double blind, unicentric. 
Masking: 
Triple (Participant, Care Provider, Investigator) 
The study drug and placebo will be packaged and labeled on the 
basis of this randomization program, being letters both, for 
placebo or Levothyroxine, coding that only the third randomization 
investigator outside the study will know. The letters of the drugs 
will be preprinted on the study drug labels and will be assigned to 
double blind treatment as the subjects meet the requirements for 
the 
study 
Both 
groups 
treated 
with 
fasting 
medication 
(levothyroxine) (in the case of taking a drug that interacts with 
absorption, use of the drug is changed according to the specified 
hours, see Table 2) or fasting placebo according to the 
randomization 1: 1 3 months 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
Participant Flow 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patients with CKD G2-G5 
without renal substitution 
therapy. (N= 163 patients) 
Levothyroxine (N= 19) 
Placebo (N= 19) 
 loss of follow-up (N=5) 

loss of tracking (N=4) 

decided not to participate(N=1) 
loss of follow-up (N=1) 

loss of tracking (N=1) 
 
Analysed (N=14) 
Analysed (N=18) 
Enrolment 
Excluded (N= 125 patients) 
 Not meeting inclusion criteria. (N=64) 
 Decline to participate. (N=56) 
 Other reasons. (N=5) 
Ramdomized 28 patients 
(N=1:1) 
Allocation 
Follow-up 
Analysis 

 
Arms and Interventions 
 
Arm 
Intervention/treatment 
Active 
Comparator: 
Group 
with 
levothyroxine 
Patients with Chronic Kidney Disease 
G2-G5 with proteinuria without renal 
replacement therapy, who comes to 
the clinic of renal health clinic of Fray 
Antonio Alcalde civil hospital. That 
meet 
the 
inclusion 
criteria. 
Levothyroxine 25 mcg (1/4 tablet of 
100mcg) was administered in fasting 
the first month, the doctor evaluated 
with monthly control of TSH levels (if 
the TSH level was not in the range of 
TSH 1-2.5 uim / L the second month 
increase to a dose of 50 mcg (1/2 
tablet of 100mcg fasting, or similarly 
if the patient had a TSH <1 u / L was 
suspended in medication and it was 
valued restart the next month the 
medication if TSH> 2.5u / L ) to 
complete 
three 
months 
of 
intervention. 
Drug: Levothyroxine  
levothyroxine with a safe dose for our 
population with high cardiovascular risk of 
0.25mcg so that the patient's weight range 
between 50-80kg maintains a dosage of 0.3-
0.5mcg / kg / day that does not affect the 
thyroid axis) fasting levothyroxine (in the case 
of taking a drug that interacts with absorption, 
use of it is changed according to the specified 
hours, see Table 2), and adjusted according to 
TSH levels > 1 and normal T4L 
Other Names: 
 
placebo 
Placebo Comparator: Group Placebo 
atients with Chronic Kidney Disease 
G2-G5 with proteinuria without renal 
replacement therapy, who comes to 
the clinic of renal health clinic of Fray 
Antonio Alcalde civil hospital. that 
meet the inclusion criteria. 
Placebo 
(1/4 
tablet) 
was 
administered in fasting the first 
month, the doctor assessed with 
monthly control of TSH levels (if the 
TSH level was not in the range of 
TSH 1-2.5 UM / L the second month 
increase at a dose (1/2 tablet fasting, 
or similarly if the patient had TSH <1 
u / L was suspended in medication 
and it was valued restart the next 
Drug: Levothyroxine  
levothyroxine with a safe dose for our 
population with high cardiovascular risk of 
0.25mcg so that the patient's weight range 
between 50-80kg maintains a dosage of 0.3-
0.5mcg / kg / day that does not affect the 
thyroid axis) fasting levothyroxine (in the case 
of taking a drug that interacts with absorption, 
use of it is changed according to the specified 
hours, see Table 2), and adjusted according to 
TSH levels > 1 and normal T4L 
Other Names: 
 
placebo 

 
 
 
 
 
 
Eligibility Criteria 
 
Ages Eligible for Study: 
18 Years and older 
Sexes Eligible for Study: 
All 
Accepts Healthy Volunteers: No 
Criteria 
Inclusion Criteria: 
 
• Patients older than 18 years 
o 
Patients with chronic kidney disease G2-G5 without renal 
replacement therapy) who attend a renal health clinic. 
o 
Presence of proteinuria in a test strip, 24 hours urine collection 
(greater than 150mg / dl in 24hrs urine) 
o 
TSH <9.9uiml / L and TSH> 2.4 0uiml / L 
o 
Take an IECA or ARA-2 
o 
Patients with weight> 50 kg and <80kg 
o 
Accept informed consent 
 
Exclusion Criteria: 
 
Chronic dialysis (peritoneal dialysis or hemodialysis) 
o 
Primary hypothyroidism or preexisting thyroid disease 
o 
Use of levothyroxine. 
o 
TSH> 10uiml / L and TSH <2.5 0uiml / L 
o 
Positive thyroid antibodies 
o 
Ischemic heart disease in less than 6 months 
o 
Cardiac arrhythmia 
o 
Use Medications (Levothyroxine synthesis, see Table 2) 
o 
Anxiety disorder 
o 
Pregnancy 
month the medication if TSH> 2.5 / 
month) to complete three months of 
intervention. 

o 
Do not accept consent 
o 
Patients weighing <50 kg and> 80kg 
 
 
 
 
 
 
Baseline Measure Information 
Table 1.  Baseline characteristics of both groups 
 
Placebo 
(n= 
14 
patients) 
Levothyroxine 
(n=18 patients) 
P value 
Sex (n=% female) 
71.42% 
55.55% 
NA 
Age (years) 
63.85 DE+/- 
15 
69.22  DE+/- 8.7 
0.41 
 
Diabetes Mellitus (yes or 
no) 
11 (78.57%) 
13 (72.22%) 
1.00 
Hypertension 
(yes or no) 
12 (85.71%) 
16 (88.88%) 
1.00 
Weigth (Kg) 
67.90 
 
+/- 
13.83 
67.01  +/- 11.32 
0.88 
Obesity (BMI >30 kg/m2) 
1 (7.14%) 
3 (6.6%) 
0.61 
ERC 
G3a 
(45-59 
ml/min/1.73m2) 
0 
3 (6.6%) 
0.23 
ERC 
G3b 
(30-44 
ml/min/1.73m2) 
2 (14.28%) 
4 (22.22%) 
0.67 
ERC 
G4 
(15-29 
ml/min/1.73m2) 
5 (35.71%) 
7 (38.88%) 
1.00 
ERC 
G5 
( 
<15 
ml/min/1.73m2) 
7 (50%) 
4 (22.22%) 
0.14 
eGFR (ml/min/1.73m2) 
9.96 +/- 18.3 
13.35 +/- 28 
0.16 
TSH (uim/L) 
4.46 +/- 1.68 
5.93 +/- 2.2 
0.02® 
Protein 
urine 
24/hours 
(gr/24hrs) 
1.28 +/- 1.28 
1.71 +/- 1.20 
0.14 
Cr.s (mg/dl) 
3.65 +/- 1.65 
2.46 +/- 1.13 
0.05® 
Albumine (mg/dl) 
3.99 +/- 0.41 
3.8 +/-0.41 
0.24 
Tryglicerides (mg/dl) 
194 +/- 75.3 
144.66  +/- 91.76 
0.09 
Cholesterol (mg/dl) 
170.57 
+/- 
45.96 
165.5 +/- 59.67 
0.67 
LDL (mg/dl) 
75.5 +/- 19 
102.38 +/- 31.42 
0.01® 
Hemoglobin (gr/dl) 
11.37 
+/- 
1.21 
11.95 +/- 1.61 
0.17 
BP systolic (mmHg) 
148.14 
+/- 
27.7 
160 +/- 19.4 
0.17 

BP diastolic (mmHg) 
79 +/- 11.72 
81.83 +/- 8.2 
0.60 
IECA o ARA-2 (n=%) 
100 
100 
1.00 
Allopurinol (n=%) 
100 
100 
1.00 
Statines (n=%) 
100 
100 
1.00 
 
 
 
 
 
Study-Specific Measure  
 
Age: 
 
Age, Continuous:  
 
Age, Categorical: 
 
>18 and <80 year 
 
Age, Customized: Customizable age categories 
 
Sex/Gender  
 
Sex: Female, Male 
 
Race and Ethnicity  
 
Race and Ethnicity Not Collected (Hispanic race) 
 
Region of Enrollment: Guadalajara, Mexico 
 
Measure Type: Mean 
Measure of Dispersion Standard Deviation 
 
Number of Baseline Participants  
38 patients ( 19 arm Levothyroxine  and 19 arm placebo) 
 
Number of Units Analyzed 32 patients ( 18 arm Levothyroxine  and 14 arm placebo) 
 
Analysis Population Type Participants  
 
Measure Analysis Population Description  
The sample size was calculated with the population size is 280 patients who attend to 
Renal Health Clinic, considering that the incidence of subclinical hypothyroidism in grade 
3-4 CKD is between 8 to 17,9% a confidence (1-alpha) of 95% = 1.96 and an error rate of 
1, the desired population is 50 patients, with 50% distribution, the recommended sample is 
13 to 25 patients in each intervention group.  
 
 
 
 
 
 

 
 
Outcome Measures 
 
Primary Outcome Measure: 
1. 24 hours urine Proteinuria in patients with subclinical hypothyroidism and CKD 
G2-G5 without renal support therapy Randomized clinical trial of levothyroxine 
group versus placebo   [Time Frame: three months] 
 
Outcome Measure Description.  Definition: Proteinuria was defined as the presence of 
proteins in the urine for 24 hours with a range greater than or equal to 0.150 grams / 24 
hours. A measurement was made at the beginning and at 3 months of the study to all 
patients 
Measure Type: mean 
Measure of Dispersion/Precision: Standard Deviation 
Number of Participants Analyzed: 32patientes 
Number of Units Analyzed: (18 arm Levothyroxine  and 14 arm placebo) 
Unit of Measure: grams/ 24 hours 
 
 
Secondary Outcome Measures: 
1. Estimated glomerular filtration rate (eGFR) in patients with subclinical 
hypothyroidism and CKD G2-G5 without renal support therapy Randomized 
clinical trial of levothyroxine group versus placebo   [Time Frame: three 
months] 
 
Outcome Measure Description [*] Definition: Outcome Measure Description [*] 
Definition: the glomerular filtration rate was calculated based on the seric creatinine 
expressed in mg / dl, the formula of CKD-EPI was use. 
Measure of Dispersion/Precision: Standard Deviation 
Number of Participants Analyzed: 32patientes 
Number of Units Analyzed: (18 arm Levothyroxine  and 14 arm placebo) 
Unit of Measure  eGFR ml/min/1.73m2 
 
2. Measurement of lipid profile (cholesterol, LDL and triglycerides) in patients 
with subclinical hypothyroidism and CKD G2-G5 without renal support therapy 
Randomized clinical trial of levothyroxine group versus placebo.   [Time 
Frame: three months] 
Outcome Measure Description. 

Definition: serum cholesterol, triglycerides and LDL cholesterol levels were measured in 
mg / dl at the beginning and at the end of three months for all patients 
 
 
Measure of Dispersion/Precision: Standard Deviation 
Number of Participants Analyzed: 32patientes 
Number of Units Analyzed: (18 arm Levothyroxine  and 14 arm placebo) 
Unit of Measure  mg/dl 
 
 
 
Statistical Analyses 
 
Type of Statistical Test: Superiority 
 
Statistical Test of Hypothesis and Method 
In the case of quantitative variables, the data are shown as average or median with 
standard deviation, according to the distribution, be it parametric or non-parametric, 
respectively. 
 
The nominal variables are shown with frequencies or percentages. 
 
For intergroup and continuous variable comparisons, in the case of qualitative variables, 
chi2 and, in the case of quantitative variables, the Student's T test or Mann-Whitney U test 
depending on the distribution of the sample. 
The statistical analysis will be carried out with the statistical program SPSS, version 20. 
 
 
 In all cases a value of p <0.05 will be accepted as significant. 
 
 
Method of Estimation (or Statistical Test of Hypothesis or Other Statistical Analysis 
required)  
 
Mean Difference (Final Values) 
 
Risk Ratio (RR) (Adverse effects) 
 
Parameter Dispersion Type : Standard Deviation 
 
 
 
Adverse Event Information 
All-Cause Mortality: no death 
Eventos adversos graves: no serious adverse event 
Other (Not Including Serious) Adverse Events: 

During the study the following adverse effects were presented: Urinary tract 
infection in a single patient of the placebo group (7.14%) and nervousness in two 
patients of the levothyroxine group (11.11%) (RR 1.55 95% CI (0.15-15.47), value 
p = 1.0). 
None left the study because of the adverse effect. Adverse events were not severe 
according to the severity scale 
 
 
 
Table of non-serious adverse events 
arm Levothyroxine  
(N=1) 7.14% 
Infections and 
Infestations (Urinary tract 
infection) 
Arm placebo 
(N=2) 11.11% 
 Psychiatric Disorder 
(Anxiety) 
 
 
Duration of urinary tract infection: five days, without complications. 
 Anxiety duration time: three days, without complications. 
 
Adverse Event Reporting Description 
with follow-up every 4 weeks, with thyroid profile control tests and adverse effects 
will be reported and follow-up. It will be valued in accordance with intensity 
According to the criteria CTC v. 3.0 (1-5), start date and end thereof, as well as the 
treatment received. 
 
Overall Limitations and Caveats  
 
Overall Limitations and Caveats At least 12 to 25 patients are needed in each arm. 
There were missed follow-ups in both arms but more in the placebo arm. 
 
 
 
 
 

 
 
 
Contacts/Locations 
Central Contact 
Person: 
Guillermo N Blackaller 
   Telephone:   013310884749 
   Email:   greenavarroblackalle@hotmail.com   
Central Contact 
Backup: 
Hospital Civil N Hospital Civil 
   Telephone:   36124578 
   Email:   greenavarroblackalle@hotmail.com   
Study Officials:  Jonathan Chavez 
Study Director 
Hospital Civil de Guadalajara   
 
Locations: Mexico 
Kidney health clinic, Civil Hospital of Guadalajara 
  
     Guadalajara, Jalisco, Mexico, 44280 
  
     Contact: Guillermo N 
Blackaller    3310884749    greenavarroblackalle@hotmail.com
     Contact: Guillermo N 
Blackaller    013310884749    greenavarroblackalle@hotmail.co
     Principal Investigator: Guillermo N Blackaller 
 
 
 
 
 
 

 
 
 
Table 2 Drugs that interact with levothyroxine 
 
Drugs that interact with the synthesis of thyroid hormones and / or Levothyroxine: 
Amiodarone, Lithium  and  Heparin 
Interactions with medications that reduce the absorption of levothyroxine: 
• Anti-acids (proton pump inhibitors) can inhibit absorption. People should take 
levothyroxine four to six hours before or after taking these antacids. 
• Iron supplements: can inhibit absorption. People should take levothyroxine four to six 
hours before or after taking these 
• Sucralfate: can inhibit absorption. People should take levothyroxine eight hours before or 
after taking these 
• Ciprofloxacin: can inhibit absorption. People should take levothyroxine four to six hours 
before or after taking these. 
• Raloxifene: can reduce the absorption of levothyroxine, although evidence to date is not 
sufficient to establish the scope of the interaction. In one case, the separation of the two 
drugs in 12 hours appeared to avoid interaction. 
• Glucocorticoids 
• Chloroquine 
• Sevelamer 
• Orlistat 
• tyrosine kinase inhibitors 
Drugs that potentiate the effect of levothyroxine 
• Salicylates (medicines used to relieve pain and reduce fever), 
• dicumarol (medicine to prevent blood clotting), 
• furosemide in high doses of 250 mg (diuretic medicine), 
• Clofibrate (medicine to reduce the level of fats in the blood). 
Effect of levothyroxine on other medications 
• Decreases the effect of oral hypoglycemic agents up to 5% 
• Increases warfarin effect 
 
 
 
 
 
 
 
 
 

 
 
PATIENT INFORMATION LETTER AND INFORMED CONSENT 
 
Name of the Principal Investigator: Guillermo Navarro Blackaller 
 
Associated Researchers: Dr. Jonathan Samuel Chávez Iñiguez  
Direction of the Principal Investigator: Civil Hospital of Guadalajara Fray Antonio Alcalde, 
Nephrology Service. Hospital 278. Colonia Centro. Guadalajara, Jalisco, Mexico. C.P. 
44240 
What is an informed consent? 
You are invited to take part in a clinical research study. Before you can make a decision to 
participate, you must understand the possible risks and benefits associated with this study. 
This process is known as informed consent, which means that you: 
• 
Receive detailed information about this research study, including any benefits 
and risks involved; 
• 
You will be invited to read, sign and date this informed consent, once you 
understand the study and want to participate. If you do not understand something about 
the study, or if you have questions, please be sure to request an explanation before you 
sign this form; 
• 
You will be given a signed and dated copy of this consent. 
 
Your participation in this study is entirely voluntary. You are not obligated to participate in 
it. Your current medical care will not be affected by your decision to participate or not in 
this study. If you refuse to participate, this does not imply any penalty or loss of benefits 
that you enjoy. You must sign this form before any study procedure is performed. 
Before you agree to participate in this study, it is very important that you understand the 
purpose of the study and the type of tests in which you will be invited to participate. The 
following information will describe the study and its role in the study. You can have a copy 
of this form to review to your liking and ask for advice from others before signing. 
 
What is the purpose of this study?  
The objective of our study is to evaluate the effects of levothyroxine on proteinuria in 
patients with chronic kidney disease. We propose a randomized clinical trial. Changes in 
proteins in 24-hour urine, estimated glomerular filtration rate, serum creatinine, cholesterol, 
blood pressure will be evaluated.  
What will I have to do to participate?  
To determine if you qualify to enter this study, you will provide a medical history and a 
thorough physical examination. You will provide a sample of urine, blood (about 2 
teaspoons) for 4 weeks 8 weeks and 12 weeks. You will take levothyroxine 25 mcg once a 
day or a placebo equivalent, for 12 weeks. The visits of the patient after starting the study 
treatment, will be every 4 weeks, where the samples already specified will be taken, and 
new medication will be delivered. 

What are the risks and discomforts?  
In previous studies, levothyroxine at that dose has been well tolerated, and no severe or 
life-threatening side effects have been reported. Among these side effects, the most 
frequent are: headache, malaise, tachycardia, diarrhea, anxiety. 
When taking blood approximately 10ml (2 tablespoons) for measurements of some studies 
required in this protocol, there are additional risks, such as discomfort associated with the 
insertion of the needle into the vein to take blood, infection, which can leave bruises 
(bruises), Temporary irritation or changes in skin color at the puncture site. Rarely can a 
person faint by taking blood. You should carefully consider all these risks with one of the 
doctors participating in the study.  
You should call the treating physician immediately if, during the course of this study, any of 
these side effects (or symptoms) or any other unforeseen side effect develops. If your 
doctor has told you that your condition aggravated, or that the side effects could be more 
severe or that new scientific developments could be discovered that indicate that this 
treatment is not in your best interest, your participation in the study should be suspended. 
 
Are there alternative treatments? 
Your alternative is to not participate in this study. Your doctor can provide you with detailed 
information about your study treatment and the benefits of various treatment options 
available to you. You have been told that you should feel free to discuss these alternatives 
(and the prognosis of your illness), as well as other available alternatives, with your doctor. 
Other options in the treatment of this condition are the use of anti-hypertensive agents 
from the IECA or ARA 2 family that are already taking, in addition to statins, allopurinol and 
aldosterone agonist agents. 
 
Will my identity and medical information be kept confidential? 
Your identity in this study will be kept confidential and the information obtained about you 
during the course of this study will remain confidential. By recording the results of the 
protocol, you will be referred to only by a code number and initials. All the information that 
refers to your participation in this research will be available to the participants of this work, 
the Ethics Committee of the Civil Hospital of Guadalajara fray Antonio Alcalde 
What are my benefits for participating? 
You may not benefit directly from your participation in this study. However, although you 
may not benefit directly from this research, in the first place there may be a benefit to 
society, in general, from the knowledge gained in relation to your participation in this 
protocol. Any information obtained from this research, which may be important to your 
health or progression of the disease, will be shared with you; we will also have knowledge 
regarding the improvement in symptoms and clinical signs as well as in the biochemical 
parameters in the follow-up of patients. 
Will I be compensated for participating? 
You will not pay for the drug. All costs for the routine treatment of kidney disease or other 
medical conditions, including any emergency, hospitalization and tests that are not 
outlined in the study protocol, will be your responsibility. If your disease progresses, you 

will be responsible for the cost of any additional diagnostic tests and treatment, as well as 
the professional fees that result. 
You (are) responsible for the cost of any medication (other than urea) that is prescribed for 
the management of your illness or concomitant diseases, during your participation in this 
study. 
 
Insurance and Financial Compensation  
In case of adverse events adjudged to the drug studied, the Civil Hospital of Guadalajara 
Fray Antonio Alcalde will NOT pay financial compensation for the treatment of medical 
complications secondary to the drug or that are part of the natural course of his primary 
disease, nor will it provide any other compensation of any kind. type to no patient. The 
medical care you will receive will not change at all, regardless of your original condition as 
a patient with kidney disease. 
What are your rights as a participant in this investigation? 
You give your consent voluntarily to participate in this clinical research study. You have 
been told what your involvement will involve, including possible risks and benefits. Your 
participation in this research project may be terminated by your doctor without your 
consent for the following reasons: (1) worsening of your health or other conditions that 
could be harmful to you if you continue to participate; (2) Failure to keep appointments or 
taking medication as directed; (3) a serious adverse event reaction (side effect) to the 
study drug; (4) start of dialysis; (5) the use of medications that have the secondary effect 
of decreasing the synthesis of thyroid hormones; . You may be withdrawn from 
participating in the study at any time, at the discretion of the study doctor for any of the 
reasons you deem appropriate. 
You may refuse to participate in this research or withdraw your consent, or also 
discontinue your participation in this study without penalty and without affecting your future 
care or your ability to receive alternative medical treatment at any of the Civil Hospitals of 
the University of Guadalajara. If you withdraw from this protocol you can seek treatment 
with another doctor of your choice. In the event that you withdraw from the study, the 
investigator will ask for your permission to continue the follow-up of the case and all the 
clinical data, which if they are related to the research work will continue to be recorded in 
your medical record 
Declaration of Irrevocable Legal Rights 
By your agreement to participate in this study, and by signing this consent form, you do not 
waive any of your legal rights.  You affirm that you have read this consent form. You have 
been informed that you will receive a copy. 
Firms 
 
____ ________ 
Patient’s name (## - Mmm - ####) 
 
____ ____ 
Name of legal representative (## - Mmm - ####) 
 
Witness Name I (## - Mmm - ####) 
 
 ______ ______ ________ 
Complete address of the witness I Relationship with the patient 

 
Witness Name II ( (## - Mmm - ####) 
 
______ ______ ________ 
Complete address of the witness II Relationship with the patient 
 
__ ________ 
Name of Principal Investigator or Signature Date 
who interviews and conducts the consent (## Mmm - ####)