NCT04658524

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

December 9, 2020

Status Verified

December 1, 2020

Enrollment Period

1.4 years

First QC Date

November 20, 2020

Last Update Submit

December 7, 2020

Conditions

Chronic Kidney DiseaseThyroid Dysfunction

Outcome Measures

Primary Outcomes (2)

  • Free thyroxine (FT4) levels in chronic kidney disease

    Free thyroxine levels through two different methods

    through study completion, an average of 3 years

  • TSH levels in chronic kidney disease

    TSH levels

    through study completion, an average of 3 years

Secondary Outcomes (2)

  • Frequency of thyroid antibodies in chronic kidney disease

    through study completion, an average of 3 years

  • Free triiodothyronine (FT3) levels in chronic kidney disease

    through study completion, an average of 3 years

Study Arms (1)

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

Interventions

Thyroid functionDIAGNOSTIC_TEST

laboratorial thyroid tests

Chonic kidney disease stages 3, 4 and 5

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic kidney disease patients followed in a Nephrology outpatient clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ana Beatriz Winter Tavares

Petrópolis, Rio de Janeiro, 25665-442, Brazil

Location

Related Publications (4)

  • Rhee CM. The interaction between thyroid and kidney disease: an overview of the evidence. Curr Opin Endocrinol Diabetes Obes. 2016 Oct;23(5):407-15. doi: 10.1097/MED.0000000000000275.

    PMID: 27428519BACKGROUND

  • Mariani LH, Berns JS. The renal manifestations of thyroid disease. J Am Soc Nephrol. 2012 Jan;23(1):22-6. doi: 10.1681/ASN.2010070766. Epub 2011 Oct 21.

    PMID: 22021708BACKGROUND

  • Meuwese CL, Gussekloo J, de Craen AJ, Dekker FW, den Elzen WP. Thyroid status and renal function in older persons in the general population. J Clin Endocrinol Metab. 2014 Aug;99(8):2689-96. doi: 10.1210/jc.2013-3778. Epub 2014 Apr 15.

    PMID: 24735423BACKGROUND

  • Scandelai KS, Vianna PDBFA, Sanches JPB, Bregman R, Tavares ABW. Correlation between thyroid function and proteinuria in patients with chronic kidney disease stages 3 and 4. Int Urol Nephrol. 2025 Dec;57(12):4309-4314. doi: 10.1007/s11255-025-04646-4. Epub 2025 Jul 5.

    PMID: 40615656DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Thyroid Function Tests

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, EndocrineDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 20, 2020

First Posted

December 8, 2020

Study Start

July 1, 2018

Primary Completion

November 30, 2019

Study Completion

December 30, 2025

Last Updated

December 9, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)