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Evaluation of Thyroid Function in Patients With Chronic Kidney Disease

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: NCT04658524
Recruitment Status : Active, not recruiting
First Posted : December 8, 2020
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Ana Beatriz Winter Tavares, Rio de Janeiro State University

Study Description
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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
Chronic Kidney Disease Thyroid Dysfunction 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
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Study Type : Observational
Estimated 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 : July 1, 2018
Actual Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Free thyroxine (FT4) levels in chronic kidney disease [ Time Frame: through study completion, an average of 3 years ]
    Free thyroxine levels through two different methods

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


Secondary Outcome Measures :
  1. Frequency of thyroid antibodies in chronic kidney disease [ Time Frame: through study completion, an average of 3 years ]
    antithyroperoxidase and antitireoglobulin antibodies

  2. Free triiodothyronine (FT3) levels in chronic kidney disease [ Time Frame: through study completion, an average of 3 years ]
    T3 levels


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Chronic kidney disease patients followed in a Nephrology outpatient clinic
Criteria

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

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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.

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Contacts and Locations
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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): NCT04658524


Locations
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Brazil
Ana Beatriz Winter Tavares
Petrópolis, RJ, Brazil, 25665-442
Sponsors and Collaborators
Rio de Janeiro State University
More Information
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Publications:

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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: December 8, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Thyroid Diseases
 Urologic Diseases
Renal Insufficiency
Endocrine System Diseases