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Thyroid Hormones in CKD

ConditionChronic Kidney Disease (Stages 4 and 5)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMario Negri Institute for Pharmacological Research

About this trial

This is a retrospective, observational, study evaluating circulating thyroid hormone profiles in patients with severe chronic kidney disease (CKD stages G4-G5, non-dialysis). The study includes one cohort of patients with non-ADPKD CKD and a second including a matched subset of patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) at the same CKD stage,.

For the non-ADPKD CKD group, serum and urine samples will be retrieved from the certified biobank of the Centro Daccò (Mario Negri IRCCS). For the ADPKD group, analyses will be performed exclusively using existing clinical and laboratory data available within the REORIENTED study database.

Laboratory measurements will be performed on stored biological samples from the non-ADPKD CKD group to assess thyroid hormones (rT3, fT3, tT3, fT4, tT4, and TSH). Clinical and laboratory data for both cohorts will be obtained from the respective study databases and linked within a predefined temporal window relative to sample collection (where applicable).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Non-ADPKD CKD

CKD stage G4, included in the ADAPT study

Availability of stored serum and urine samples in the biobank suitable for thyroid hormone analysis

Availability of relevant clinical and laboratory data within a predefined time window from sample collection

Disqualifiers

Known history of thyroid disease (hypothyroidism, hyperthyroidism, thyroiditis, or thyroid cancer)

Treatment with thyroid hormone replacement or antithyroid drugs

Use of medications known to interfere with thyroid function (e.g., amiodarone, lithium, interferon)

Systemic corticosteroid or immunosuppressive therapy at the time of sampling (if data available)

Trial population

1. Non-ADPKD CKD group Patients with severe chronic kidney disease (CKD stages G4-G5, not on dialysis) previously enrolled in the ADAPT clinical study (NCT04794517) conducted at the Clinical Research Center for Rare Diseases "Aldo e Cele Daccò", Istituto di Ricerche Farmacologiche Mario Negri IRCCS will be included. Only patients who provided informed consent for storage and future research use of biological samples and associated clinical data will be included. 2. ADPKD group A subset of patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) previously enrolled in the REORIENTED clinical study (NCT05646420), will be selected. These patients will be included only if they present the same CKD stage (G4-G5) as the non-ADPKD CKD group, in order to ensure comparability in terms of renal function impairment.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Laboratory measurements

    Other intervention

    Reverse T3 will be measured using a dedicated ELISA assay. Total T3, total T4, free T3, free T4, and TSH will be measured using chemiluminescent immunoassays according to the standard operating procedures of the Laboratory of Clinical Chemistry

Treatment groups

51 Participants
are divided into 2 treatment groups
Group A: Non-ADPKD CKD group1 intervention
Group B: ADPKD group1 intervention

Trial outcomes

Primary outcomes

1

Serum rT3

Serum rT3 levels (ng/ml) will be measured using the reverse Triiodothyronine ELISA Test System Kit (Cat#CAN-RT3-100, Diagnostic Biochem Canada) following the manufacturer's instructions.

Time frame
One single measurement at baseline
2

Urine rT3

Urine rT3 levels (ng/dl or pg/ml) will be measured using the Triiodothyronine ELISA Test System Kit (Cat# EIA-RT3, Ray biotech or Cat# EK711381 AFG Bioscience) following the manufacturer's instructions.

Time frame
One single measurement at baseline
3

Serum free T3

Serum free T3 (pg/ml) will be measured at the Laboratory of Clinical Chemistry of the Centro Daccò with a Chemiluminescent immunoassay according to the local standard Operating procedures.

Time frame
One single measurement at baseline
4

Serum free T4

Serum free T4 (ng/dl) will be measured at the Laboratory of Clinical Chemistry of the Centro Daccò with a Chemiluminescent immunoassay according to the local standard Operating procedures

Time frame
One single measurement at baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mario Negri Institute for Pharmacological Research

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: