Interleukin-6 and Thyroid Dysfunction in Hemodialysis Patients

January 2, 2026 updated by: Dr. Soetomo General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • East Java
      • Surabaya, East Java, Indonesia, 60115
        • Airlangga University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline, during routine hemodialysis visit (prior to any study-specific intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Both IL-6 (pg/mL) and T3 (ng/dL) will be measured using immunoassay. The outcome is the Spearman correlation coefficient.
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)
IL-6 (pg/mL) and total T4 (µg/dL) will be quantified using immunoassay. Outcome is the correlation coefficient (Spearman r).
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)
IL-6 (pg/mL) and free T3 (pg/mL) measured using immunoassay analyzer. Outcome is Spearman correlation coefficient.
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)
IL-6 (pg/mL) and fT4 (ng/dL) measured using immunoassay. Outcome is Spearman correlation coefficient (spearman r).
At baseline, during routine hemodialysis visit (prior to any study-specific intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Soetomo General Hospital

Collaborators

Universitas Airlangga Hospital, Surabaya

Investigators

  • Principal Investigator: Sony Wibisono Mudjanarko, dr., Sp.PD, K-EMD, PhD, Dr. Soetomo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 175/KEP/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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