Chronic Kidney Disease on HemodialysisNCT07328113
Interleukin-6 and Thyroid Dysfunction in Hemodialysis Patients
An observational study of Chronic Kidney Disease on Hemodialysis and Thyroid Gland Disease, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
Trial summary
Chronic kidney disease (CKD) is often associated with multiorgan complications, including thyroid hormone dysfunction. Interleukin-6 (IL-6), a pro-inflammatory cytokine, has been proposed as a marker of inflammation that may contribute to these alterations. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Kidney Disease on Hemodialysis, Thyroid Gland Disease
- What is being tested?
- Thyroid hormone
- How many people
- 65 participants
- Where
- 1 siteIndonesia
- Study dates
- 14 Nov 2023to 30 Jun 2024
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population consists of all ESRD patients aged ≥ 21 years who undergo examinations at the Dialysis Unit of Universitas Airlangga Hospital, Surabaya. The accessible population includes all ESRD patients aged ≥ 21 years who undergo examinations at the Dialysis Unit of Universitas Airlangga Hospital, Surabaya, during the study period.
Who may be able to join
- Age 21 Years Old and above
- Patients with ESRD who have undergone hemodialysis for ≥ 3 months and are in stable condition.
- Patients are able to communicate and respond to questions appropriately
- Patients are willing to participate in the study.
Who cannot join
- ESRD patients undergoing hemodialysis who have been diagnosed with underlying thyroid disorders or thyroid malignancy.
- Patients with a history of thyroid surgery or any intervention involving the thyroid gland.
- Patients with a family history of thyroid disorders.
- Patients taking medications that affect thyroid function or using antioxidant drugs.
- Patients with infection or sepsis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Interleukin-6 and Thyroid Hormone Dysfunction in Patients With Chronic Kidney Disease Undergoing Hemodialysis
Chronic kidney disease (CKD) is often associated with multiorgan complications, including thyroid hormone dysfunction. Interleukin-6 (IL-6), a pro-inflammatory cytokine, has been proposed as a marker of inflammation that may contribute to these alterations. The main question it aims to answer is:
Is there an association between interleukin-6 and thyroid hormone dysfunction in patients with chronic kidney disease (CKD) Blood samples will be collected and analyzed from 65 patients who have undergone hemodialysis for at least 3 months.
Read the detailed description
This cross-sectional observational study involves patients with CKD undergoing hemodialysis at Airlangga University Hospital. Data were collected based on their medical record and Blood test for IL-6. Linear regression analysis assessed the relationship between IL-6 levels and thyroid function parameters.
- Being tested
- Thyroid hormone
- Keywords
- Interleukin-6, Thyroid Function, Chronic Kidney Disease, Hemodialysis
- Medical subject headings
- Thyroid Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid hormoneDiagnostic test
Also called Interleukin-6
Sampling was carried out using a consecutive sampling method, in which every patient who met the study criteria was included as a sample until the predetermined sample size was achieved. Patients who had been confirmed to meet the inclusion and exclusion criteria underwent blood collection of 10 mL (serum or plasma) prior to hemodialysis for the examination of complete blood count, BUN, creatinine, albumin, fasting blood glucose, IL-6, FT4, T3, FT3, T4, and TSH.
The IL-6 level was measured using the Automatic Immunoassay Fluorescence method with the Automatic Fluorescence Immunoassay Analyzer Vazyme QD-S2000. Thyroid function tests (FT4, T3, T4, FT3, and TSH) were performed using the Enzyme-Linked Immunosorbent Assay (ELISA) method with Autobio Immunoassay reagents on the Autobio A1000 analyzer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between serum Interleukin-6 (IL-6) concentration and serum Thyroid-Stimulating Hormone (TSH) levels
Serum IL-6 (pg/mL) and TSH (µIU/mL) will be measured using standardized hospital laboratory immunoassay analyzers. The outcome is the correlation coefficient (Spearman r) between IL-6 and TSH.
Measured: At baseline, during routine hemodialysis visit (prior to any study-specific intervention)
Secondary outcomes (4)
Correlation between serum IL-6 concentration and serum Total Triiodothyronine (T3) levels
Both IL-6 (pg/mL) and T3 (ng/dL) will be measured using immunoassay. The outcome is the Spearman correlation coefficient.
Measured: At baseline, during routine hemodialysis visit (prior to any study-specific intervention)
Correlation between serum IL-6 concentration and serum Total Thyroxine (T4) levels
IL-6 (pg/mL) and total T4 (µg/dL) will be quantified using immunoassay. Outcome is the correlation coefficient (Spearman r).
Measured: At baseline, during routine hemodialysis visit (prior to any study-specific intervention)
Correlation between serum IL-6 concentration and Free Triiodothyronine (fT3) levels
IL-6 (pg/mL) and free T3 (pg/mL) measured using immunoassay analyzer. Outcome is Spearman correlation coefficient.
Measured: At baseline, during routine hemodialysis visit (prior to any study-specific intervention)
Correlation between serum IL-6 concentration and Free Thyroxine (fT4) levels
IL-6 (pg/mL) and fT4 (ng/dL) measured using immunoassay. Outcome is Spearman correlation coefficient (spearman r).
Measured: At baseline, during routine hemodialysis visit (prior to any study-specific intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start14 Nov 2023
- Primary completion31 Mar 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease on HemodialysisStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Collaborators
- Universitas Airlangga Hospital, Surabaya
- Responsible party
- Sponsor
- Investigators
- Sony Wibisono Mudjanarko, dr., Sp.PD, K-EMD, PhD, Principal investigator, Dr. Soetomo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328113
- Sponsor's protocol ID
- 175/KEP/2023
- Status last verified
- Oct 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Interleukin-6 and Thyroid Hormone Dysfunction in Patients With Chronic Kidney Disease Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT07328113
- Acronym / sponsor ID
- 175/KEP/2023
- Keywords
- Interleukin-6, Thyroid Function, Chronic Kidney Disease, Hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Collaborators
- Universitas Airlangga Hospital, Surabaya
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 8 Jan 2026 (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.
Chronic kidney disease (CKD) is often associated with multiorgan complications, including thyroid hormone dysfunction. Interleukin-6 (IL-6), a pro-inflammatory cytokine, has been proposed as a marker of inflammation that may contribute to these alterations. The main question it aims to answer is:
Is there an association between interleukin-6 and thyroid hormone dysfunction in patients with chronic kidney disease (CKD) Blood samples will be collected and analyzed from 65 patients who have undergone hemodialysis for at least 3 months.
Detailed description
This cross-sectional observational study involves patients with CKD undergoing hemodialysis at Airlangga University Hospital. Data were collected based on their medical record and Blood test for IL-6. Linear regression analysis assessed the relationship between IL-6 levels and thyroid function parameters.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population consists of all ESRD patients aged ≥ 21 years who undergo examinations at the Dialysis Unit of Universitas Airlangga Hospital, Surabaya. The accessible population includes all ESRD patients aged ≥ 21 years who undergo examinations at the Dialysis Unit of Universitas Airlangga Hospital, Surabaya, during the study period.
Key inclusion criteria (4 listed)
- Age 21 Years Old and above
- Patients with ESRD who have undergone hemodialysis for ≥ 3 months and are in stable condition.
- Patients are able to communicate and respond to questions appropriately
- Patients are willing to participate in the study.
Key exclusion criteria (5 listed)
- ESRD patients undergoing hemodialysis who have been diagnosed with underlying thyroid disorders or thyroid malignancy.
- Patients with a history of thyroid surgery or any intervention involving the thyroid gland.
- Patients with a family history of thyroid disorders.
- Patients taking medications that affect thyroid function or using antioxidant drugs.
- Patients with infection or sepsis.
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 hormoneAlso: Interleukin-6Sampling was carried out using a consecutive sampling method, in which every patient who met the study criteria was included as a sample until the predetermined sample size was achieved. Patients who had been confirmed to meet the inclusion and exclusion criteria underwent blood collection of 10 mL (serum or plasma) prior to hemodialysis for the examination of complete blood count, BUN, creatinine, albumin, fasting blood glucose, IL-6, FT4, T3, FT3, T4, and TSH. The IL-6 level was measured using the Automatic Immunoassay Fluorescence method with the Automatic Fluorescence Immunoassay Analyzer Vazyme QD-S2000. Thyroid function tests (FT4, T3, T4, FT3, and TSH) were performed using the Enzyme-Linked Immunosorbent Assay (ELISA) method with Autobio Immunoassay reagents on the Autobio A1000 analyzer. | Diagnostic test | – |
Primary outcome
Correlation between serum Interleukin-6 (IL-6) concentration and serum Thyroid-Stimulating Hormone (TSH) levels
Time frame: At baseline, during routine hemodialysis visit (prior to any study-specific intervention)
Serum IL-6 (pg/mL) and TSH (µIU/mL) will be measured using standardized hospital laboratory immunoassay analyzers. The outcome is the correlation coefficient (Spearman r) between IL-6 and TSH.
4 secondary outcomes
Correlation between serum IL-6 concentration and serum Total Triiodothyronine (T3) levels
Time frame: At baseline, during routine hemodialysis visit (prior to any study-specific intervention)
Correlation between serum IL-6 concentration and serum Total Thyroxine (T4) levels
Time frame: At baseline, during routine hemodialysis visit (prior to any study-specific intervention)
Correlation between serum IL-6 concentration and Free Triiodothyronine (fT3) levels
Time frame: At baseline, during routine hemodialysis visit (prior to any study-specific intervention)
Correlation between serum IL-6 concentration and Free Thyroxine (fT4) levels
Time frame: At baseline, during routine hemodialysis visit (prior to any study-specific intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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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.
Sony Wibisono Mudjanarko, dr., Sp.PD, K-EMD, PhD principal investigator
Dr. Soetomo General Hospital
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 on Hemodialysis and Thyroid Gland Disease, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 8 Jan 2026. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between serum Interleukin-6 (IL-6) concentration and serum Thyroid-Stimulating Hormone (TSH) levels (time frame: At baseline, during routine hemodialysis visit (prior to any study-specific intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2026.