Clinical trial NCT04658524: Evaluation of Thyroid Function in Patients With Chronic Kidney Disease
Official title: Evaluation of Thyroid Function in Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Kidney Disease
Thyroid Dysfunction
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic kidney disease patients followed in a Nephrology outpatient clinic

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).

Eligibility 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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Primary outcomes:
measure: Free thyroxine (FT4) levels in chronic kidney disease
timeFrame: through study completion, an average of 3 years
measure: TSH levels in chronic kidney disease
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: Frequency of thyroid antibodies in chronic kidney disease
timeFrame: through study completion, an average of 3 years
measure: Free triiodothyronine (FT3) levels in chronic kidney disease
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Petrópolis
country: Brazil
facility: Ana Beatriz Winter Tavares
state: RJ
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.