Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03898622
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Guillermo Navarro Blackaller, Hospital Civil de Guadalajara

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Subclinical Hypothyroidism Drug: Levothyroxine Phase 3

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])


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase II study, type placebo controlled clinical trial, randomized of two arms, double blind, unicentric.
Masking: Triple (Participant, Care Provider, Investigator)
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
Primary Purpose: Treatment
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.
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : March 1, 2019


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 Name: 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 month the medication if TSH> 2.5 / month) 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 Name: placebo




Primary Outcome Measures :
  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 ]
    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 :
  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 ]
    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).

  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 ]
    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).


Other Outcome Measures:
  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) when using levothyroxine in patients with subclinical hypothyroidism and CKD [ Time Frame: four months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898622


Locations
Layout table for location information
Mexico
Kidney health clinic, Civil Hospital of Guadalajara
Guadalajara, Jalisco, Mexico, 44280
Sponsors and Collaborators
Hospital Civil de Guadalajara
Investigators
Layout table for investigator information
Study Director: Jonathan Chavez Hospital Civil de Guadalajara
  Study Documents (Full-Text)

Documents provided by Guillermo Navarro Blackaller, Hospital Civil de Guadalajara:

Layout table for additonal information
Responsible Party: Guillermo Navarro Blackaller, resident of nephrology, Hospital Civil de Guadalajara
ClinicalTrials.gov Identifier: NCT03898622     History of Changes
Other Study ID Numbers: HospitalCG 034/18
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Hypothyroidism
Urologic Diseases
Renal Insufficiency
Thyroid Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs