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

NCT03898622 | Completed Phase 3

• 1 other identifier: HospitalCG 034/18
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Subclinical Hypothyroidism

Outcome Measures

Primary Outcomes (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

  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).

  three months

Secondary Outcomes (2)

• 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

  three months

• 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.

  three months

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) when using levothyroxine in patients with subclinical hypothyroidism and CKD

  four months

Study Arms (2)

Group with levothyroxine

ACTIVE COMPARATOR

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

Group Placebo

PLACEBO COMPARATOR

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.

Drug: Levothyroxine

Interventions

Levothyroxine DRUG

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

Also known as: placebo

Group Placebo; Group with levothyroxine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (1)

Kidney health clinic, Civil Hospital of Guadalajara

Guadalajara, Jalisco, 44280, Mexico

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jonathan Chavez

  Hospital Civil de Guadalajara

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident of nephrology

Model Details: Phase II study, type placebo controlled clinical trial, randomized of two arms, double blind, unicentric.

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: April 2, 2019
• Study Start: October 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: March 1, 2019
• Last Updated: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)