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Supplementation of Thyroid Hormone for TSH Control in Patients With Chronic Kidney Disease Without TRR. (TSHrenal)

Primary Purpose

Chronic Kidney Diseases, Subclinical Hypothyroidism

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Levothyroxine
Sponsored by
Hospital Civil de Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Patients older than 18 years

    • Patients with chronic kidney disease G2-G5 without renal replacement therapy) who attend a renal health clinic.
    • Presence of proteinuria in a test strip, 24 hours urine collection (greater than 150mg / dl in 24hrs urine)
    • TSH <9.9uiml / L and TSH> 2.4 0uiml / L
    • Take an IECA or ARA-2
    • Patients with weight> 50 kg and <80kg
    • Accept informed consent

Exclusion Criteria:

  • Chronic dialysis (peritoneal dialysis or hemodialysis)

    • Primary hypothyroidism or preexisting thyroid disease
    • Use of levothyroxine.
    • TSH> 10uiml / L and TSH <2.5 0uiml / L
    • Positive thyroid antibodies
    • Ischemic heart disease in less than 6 months
    • Cardiac arrhythmia
    • Use Medications (Levothyroxine synthesis, see Table 2)
    • Anxiety disorder
    • Pregnancy
    • Do not accept consent
    • Patients weighing <50 kg and> 80kg

Sites / Locations

  • Kidney health clinic, Civil Hospital of Guadalajara

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group with levothyroxine

Group Placebo

Arm Description

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.

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 month the medication if TSH> 2.5 / month) to complete three months of intervention.

Outcomes

Primary Outcome Measures

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
24 hours urine Proteinuria in patients with subclinical hypothyroidism and chronic kidney disease G2-G5 without renal support therapy, in two study arms the first in patients with the use of levothyroxine in 18 patients (TSH in a safe range 1-2.5 μm / L ), in patients who already use ACE inhibitors or ARA-2 (at least 3 months), versus the second arm in patients with subclinical hypothyroidism and chronic kidney disease G2-G5 without renal support therapy in patients who already use ACE inhibitors or ARA- 2 (at least 3 months) with placebo in 14 patients, Based on proteins in 24-hour urine collection at the beginning and end of three months. with follow-up every 4 weeks (Monitoring thyroid function and adjusting dose in a safe range TSH 1-2.5uim / L).

Secondary Outcome Measures

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
Estimated glomerular filtration rate in patients with subclinical hypothyroidism and chronic kidney disease G2-G5 without renal support therapy, in two study arms the first in patients with the use of levothyroxine in 18 patients (TSH in a safe range 1-2.5 μm / L), versus the second arm in patients with subclinical hypothyroidism and chronic kidney disease G2-G5 without renal support therapy with placebo in 14 patients, Based on the measurement of creatinine serica (MDRD formula was used to calculate eGFR expressed in ml/min/1.73m2) at the beginning and end of three months. with follow-up every 4 weeks (Monitoring thyroid function and adjusting dose in a safe range TSH 1-2.5uim / L).
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.
Measurement of lipid profile (Cholesterol, LDL cholesterol and triglycerides) in patients with subclinical hypothyroidism and chronic kidney disease G2-G5 without renal support therapy, in two studies in the patients with the use of levothyroxine in 18 patients (TSH in a safe range 1-2.5 μm / L), versus the second arm in patients with subclinical hypothyroidism and chronic kidney disease G2-G5 without renal support therapy with placebo in 14 patients, Based on the measurement of cholesterol, triglycerides and serum LDL expressed in mg / dl at the beginning and end of three months. with follow-up every 4 weeks (Monitoring thyroid function and adjusting dose in a safe range TSH 1-2.5uim / L).

Full Information

First Posted
August 28, 2018
Last Updated
March 29, 2019
Sponsor
Hospital Civil de Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT03898622
Brief Title
Supplementation of Thyroid Hormone for TSH Control in Patients With Chronic Kidney Disease Without TRR.
Acronym
TSHrenal
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Civil de Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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])

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Subclinical Hypothyroidism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase II study, type placebo controlled clinical trial, randomized of two arms, double blind, unicentric.
Masking
ParticipantCare ProviderInvestigator
Masking Description
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
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group with levothyroxine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group Placebo
Arm Type
Placebo Comparator
Arm Description
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 month the medication if TSH> 2.5 / month) to complete three months of intervention.
Intervention Type
Drug
Intervention Name(s)
Levothyroxine
Other Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
24 hours urine Proteinuria in patients with subclinical hypothyroidism and chronic kidney disease G2-G5 without renal support therapy, in two study arms the first in patients with the use of levothyroxine in 18 patients (TSH in a safe range 1-2.5 μm / L ), in patients who already use ACE inhibitors or ARA-2 (at least 3 months), versus the second arm in patients with subclinical hypothyroidism and chronic kidney disease G2-G5 without renal support therapy in patients who already use ACE inhibitors or ARA- 2 (at least 3 months) with placebo in 14 patients, Based on proteins in 24-hour urine collection at the beginning and end of three months. with follow-up every 4 weeks (Monitoring thyroid function and adjusting dose in a safe range TSH 1-2.5uim / L).
Time Frame
three months
Secondary Outcome Measure Information:
Title
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
Description
Estimated glomerular filtration rate in patients with subclinical hypothyroidism and chronic kidney disease G2-G5 without renal support therapy, in two study arms the first in patients with the use of levothyroxine in 18 patients (TSH in a safe range 1-2.5 μm / L), versus the second arm in patients with subclinical hypothyroidism and chronic kidney disease G2-G5 without renal support therapy with placebo in 14 patients, Based on the measurement of creatinine serica (MDRD formula was used to calculate eGFR expressed in ml/min/1.73m2) at the beginning and end of three months. with follow-up every 4 weeks (Monitoring thyroid function and adjusting dose in a safe range TSH 1-2.5uim / L).
Time Frame
three months
Title
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.
Description
Measurement of lipid profile (Cholesterol, LDL cholesterol and triglycerides) in patients with subclinical hypothyroidism and chronic kidney disease G2-G5 without renal support therapy, in two studies in the patients with the use of levothyroxine in 18 patients (TSH in a safe range 1-2.5 μm / L), versus the second arm in patients with subclinical hypothyroidism and chronic kidney disease G2-G5 without renal support therapy with placebo in 14 patients, Based on the measurement of cholesterol, triglycerides and serum LDL expressed in mg / dl at the beginning and end of three months. with follow-up every 4 weeks (Monitoring thyroid function and adjusting dose in a safe range TSH 1-2.5uim / L).
Time Frame
three months
Other Pre-specified Outcome Measures:
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) when using levothyroxine in patients with subclinical hypothyroidism and CKD
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.
Time Frame
four months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Patients older than 18 years Patients with chronic kidney disease G2-G5 without renal replacement therapy) who attend a renal health clinic. Presence of proteinuria in a test strip, 24 hours urine collection (greater than 150mg / dl in 24hrs urine) TSH <9.9uiml / L and TSH> 2.4 0uiml / L Take an IECA or ARA-2 Patients with weight> 50 kg and <80kg Accept informed consent Exclusion Criteria: Chronic dialysis (peritoneal dialysis or hemodialysis) Primary hypothyroidism or preexisting thyroid disease Use of levothyroxine. TSH> 10uiml / L and TSH <2.5 0uiml / L Positive thyroid antibodies Ischemic heart disease in less than 6 months Cardiac arrhythmia Use Medications (Levothyroxine synthesis, see Table 2) Anxiety disorder Pregnancy Do not accept consent Patients weighing <50 kg and> 80kg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Chavez
Organizational Affiliation
Hospital Civil de Guadalajara
Official's Role
Study Director
Facility Information:
Facility Name
Kidney health clinic, Civil Hospital of Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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Supplementation of Thyroid Hormone for TSH Control in Patients With Chronic Kidney Disease Without TRR.

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