Thyroid Hormones in CKD

NCT07663773 · tracked via the Priya Life Science Italy tracker

Sponsor

Mario Negri Institute for Pharmacological Research

Phase

Observational

Started

2026-09

Last updated

2026-06-23

Condition(s) studied

Chronic Kidney Disease (Stages 4 and 5)

Investigational drug(s) / intervention(s)

Laboratory measurements

Laboratory measurements: 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

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion criteria * 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 * Signed informed consent for storage and future research use of biological samples and clinical data * ADPKD CKD * CKD stage G4, included in the REORIENTED study * Availability of complete thyroid hormone profile and relevant clinical data Exclusion criteria (applied to both groups as far as possible) * 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) * Dialysis treatment or history of kidney transplantation at the time of sampling * Acute illness, infection, or hospitalization close to the time of sample collection (if identifiable)

Primary outcome measure(s)

Serum rT3 — One single measurement at baseline
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.
Urine rT3 — One single measurement at baseline
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.
Serum free T3 — One single measurement at baseline
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.
Serum free T4 — One single measurement at baseline
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
Serum TSH — One single measurement at baseline
Serum TSH (microU/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

Trial sites (1)

Facility	City	Region	Status
Clinical Research Centre for Rare Diseases Aldo e Cele Daccò	Ranica	BG

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07663773 on ClinicalTrials.gov ↗ ← All trials in Italy