Evaluation of Thyroid Function in Patients With Chronic Kidney Disease

Active, not recruiting

• Conditions: Thyroid Dysfunction; Chronic Kidney Disease
• Interventions: Diagnostic Test: Thyroid function

• Registration Number: NCT04658524
• Lead Sponsor: Rio de Janeiro State University

Brief Summary

A higher prevalence of thyroid disease has been associated with chronic kidney disease (CKD), and subclinical hypothyroidism seems to be the most common dysfunction. The aim is to evaluate thyroid function and autoimmunity in patients with CKD stages 3, 4 and 5. Cross-sectional study to be carried out on patients with stages 3 and 4 in a Nephrology outpatient clinic. Thyroid function is evaluated by measuring thyroid stimulating hormone (TSH), free thyroxine, free triiodothyronine and antithyroperoxidase antibodies (TPOAb) levels.

Detailed Description

Cross-sectional study to be carried out on patients with stages 3, 4 and 5 in a Nephrology outpatient clinic. Thyroid function is evaluated by measuring thyroid stimulating hormone (TSH), free thyroxine, free triiodothyronine and antithyroperoxidase antibodies (TPOAb) levels. Free Thyroxine (FT4) will be measured by liquid chromatography tandem mass spectrometry and electrochemiluminescence immunoassay in order to compare methods in this population.

The glomerular filtration rate was estimated (eGFR) by the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI), and the CKD stages were defined according to the Kidney Disease Improving Global Outcomes directives (KDIGO).

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2019-11-30
• Study First Submitted: 2020-11-20
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-01
• Last Update Submitted: 2020-12-07
• Study First Posted: 2020-12-08
• Last Update Posted: 2020-12-09
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Patients over 18 years old with CKD stages 3 and 4 were included in the study.

Exclusion Criteria

1. acute systemic inflammatory disease; 2) pituitary disease in the past or present; 3) regular treatment with amiodarone, lithium, interferon, immunosuppressive drugs and glucocorticoids; 4) previously diagnosed hypothyroidism and undergoing levothyroxine replacement.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chonic kidney disease stages 3, 4 and 5	Thyroid function	Patients with stage chronic kidney disease stages 3, 4 and 5. CKD stages were defined according to the Kidney Disease Improving Global Outcomes directives (KDIGO): a) stage 3A: eGFR 45 and 59 ml/min/1.73m2; b) stage 3B: eGFR between 30 and 44 ml/min/1.73m2; c) stage 4: eGFR between 15 and 29 ml/min/1.73 m2

Primary Outcome Measures

Name	Time	Method
Free thyroxine (FT4) levels in chronic kidney disease	through study completion, an average of 3 years	Free thyroxine levels through two different methods
TSH levels in chronic kidney disease	through study completion, an average of 3 years	TSH levels

Secondary Outcome Measures

Name	Time	Method
Free triiodothyronine (FT3) levels in chronic kidney disease	through study completion, an average of 3 years	T3 levels
Frequency of thyroid antibodies in chronic kidney disease	through study completion, an average of 3 years	antithyroperoxidase and antitireoglobulin antibodies

Trial Locations

Locations (1)

Ana Beatriz Winter Tavares; 🇧🇷 Petrópolis, RJ, Brazil