Evaluation of Thyroid Function in Patients With Chronic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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RJ
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Petrópolis, RJ, Brazil, 25665-442
- Ana Beatriz Winter Tavares
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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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Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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laboratorial thyroid tests
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Free thyroxine (FT4) levels in chronic kidney disease
Time Frame: through study completion, an average of 3 years
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Free thyroxine levels through two different methods
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through study completion, an average of 3 years
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TSH levels in chronic kidney disease
Time Frame: through study completion, an average of 3 years
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TSH levels
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through study completion, an average of 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of thyroid antibodies in chronic kidney disease
Time Frame: through study completion, an average of 3 years
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antithyroperoxidase and antitireoglobulin antibodies
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through study completion, an average of 3 years
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Free triiodothyronine (FT3) levels in chronic kidney disease
Time Frame: through study completion, an average of 3 years
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T3 levels
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through study completion, an average of 3 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3.138.270
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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