Evaluation of Thyroid Function in Patients With Chronic Kidney Disease

Sponsor
Rio de Janeiro State University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04658524
Collaborator
(none)
44
1
90
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Thyroid function

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 Design

Study Type:
Observational
Anticipated Enrollment :
44 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Thyroid Function in Patients With Chronic Kidney Disease
Actual Study Start Date :
Jul 1, 2018
Actual Primary Completion Date :
Nov 30, 2019
Anticipated Study Completion Date :
Dec 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Chonic kidney disease stages 3, 4 and 5

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

Diagnostic Test: Thyroid function
laboratorial thyroid tests

Outcome Measures

Primary Outcome Measures

  1. Free thyroxine (FT4) levels in chronic kidney disease [through study completion, an average of 3 years]

    Free thyroxine levels through two different methods

  2. TSH levels in chronic kidney disease [through study completion, an average of 3 years]

    TSH levels

Secondary Outcome Measures

  1. Frequency of thyroid antibodies in chronic kidney disease [through study completion, an average of 3 years]

    antithyroperoxidase and antitireoglobulin antibodies

  2. Free triiodothyronine (FT3) levels in chronic kidney disease [through study completion, an average of 3 years]

    T3 levels

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All

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.

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ana Beatriz Winter Tavares PetrĂ³polis RJ Brazil 25665-442

Sponsors and Collaborators

  • Rio de Janeiro State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ana Beatriz Winter Tavares, Professor, Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT04658524
Other Study ID Numbers:
  • 3.138.270
First Posted:
Dec 8, 2020
Last Update Posted:
Dec 9, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2020