Chronic Kidney Disease Clinical Trial
Official title:
Evaluation of Thyroid Function in Patients With Chronic Kidney Disease
| Verified date | December 2020 |
| Source | Rio de Janeiro State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 44 |
| Est. completion date | December 30, 2025 |
| Est. primary completion date | November 30, 2019 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility | 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. - |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Ana Beatriz Winter Tavares | Petrópolis | RJ |
| Lead Sponsor | Collaborator |
|---|---|
| Rio de Janeiro State University |
Brazil,
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. Review. — View 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. — View 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. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Free thyroxine (FT4) levels in chronic kidney disease | Free thyroxine levels through two different methods | through study completion, an average of 3 years | |
| Primary | TSH levels in chronic kidney disease | TSH levels | through study completion, an average of 3 years | |
| Secondary | Frequency of thyroid antibodies in chronic kidney disease | antithyroperoxidase and antitireoglobulin antibodies | through study completion, an average of 3 years | |
| Secondary | Free triiodothyronine (FT3) levels in chronic kidney disease | T3 levels | through study completion, an average of 3 years |
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|---|---|---|---|
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