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

NCT03898622 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-04-02

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Diseases
  • Subclinical Hypothyroidism

Interventions

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

Sponsors & Collaborators

  • Hospital Civil de Guadalajara

    lead OTHER

Principal Investigators

  • Jonathan Chavez · Hospital Civil de Guadalajara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-01-31
Completion
2019-03-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03898622 on ClinicalTrials.gov