Chronic Kidney DiseaseNCT04658524
Evaluation of Thyroid Function in Patients With Chronic Kidney Disease
An observational study of Chronic Kidney Disease and Thyroid Dysfunction, run by Rio de Janeiro State University at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Kidney Disease, Thyroid Dysfunction
- What is being tested?
- Thyroid function
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2018to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Chronic kidney disease patients followed in a Nephrology outpatient clinic
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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Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Chronic Kidney Disease, Thyroid Dysfunction
- Being tested
- Thyroid function
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid functionDiagnostic test
laboratorial thyroid tests
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Thyroid function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free thyroxine (FT4) levels in chronic kidney disease
Free thyroxine levels through two different methods
Measured: through study completion, an average of 3 years
TSH levels in chronic kidney disease
TSH levels
Measured: through study completion, an average of 3 years
Secondary outcomes (2)
Frequency of thyroid antibodies in chronic kidney disease
antithyroperoxidase and antitireoglobulin antibodies
Measured: through study completion, an average of 3 years
Free triiodothyronine (FT3) levels in chronic kidney disease
T3 levels
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Jul 2018
- Primary completion30 Nov 2019
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Beatriz Winter Tavares, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658524
- Sponsor's protocol ID
- 3.138.270
- Status last verified
- Dec 2020
- First submitted
- 20 Nov 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27428519Mariani 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.
PubMed 22021708Meuwese 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.
PubMed 24735423Scandelai 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.
PubMed 40615656
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thyroid Function in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04658524
- Acronym / sponsor ID
- 3.138.270
- Conditions
- Chronic Kidney Disease, Thyroid Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chonic kidney disease stages 3, 4 and 5 | – | Diagnostic Test: Thyroid functionPatients 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chronic kidney disease patients followed in a Nephrology outpatient clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid functionlaboratorial thyroid tests | Diagnostic test | Chonic kidney disease stages 3, 4 and 5 |
Primary outcome
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
TSH levels in chronic kidney disease
Time frame: through study completion, an average of 3 years
TSH levels
2 secondary outcomes
Frequency of thyroid antibodies in chronic kidney disease
Time frame: through study completion, an average of 3 years
Free triiodothyronine (FT3) levels in chronic kidney disease
Time frame: through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Background: PubMed 27428519Rhee 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.
- Background: PubMed 22021708Mariani 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.
- Background: PubMed 24735423Meuwese 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.
- Derived from this study: PubMed 40615656Scandelai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Thyroid Dysfunction, run by Rio de Janeiro State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free thyroxine (FT4) levels in chronic kidney disease (time frame: through study completion, an average of 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04658524, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.