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Thyroid Hormones in CKD (THYROID-CKD)

Deciphering the Role of Thyroid Hormones in Severe Non-ADPKD Chronic Kidney Disease

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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Intervention / Traitement

Description détaillée

Chronic kidney disease (CKD) is frequently associated with alterations in thyroid hormone homeostasis, commonly referred to as Non-Thyroidal Illness Syndrome (NTIS) or "low T3 syndrome" . This condition is typically characterized by reduced circulating levels of free triiodothyronine (fT3) in the presence of normal or slightly decreased Thyroid-Stimulating Hormone (TSH) and free thyroxine (fT4), and has been associated with inflammation, protein-energy wasting, and the severity of renal dysfunction.

While these hormonal changes are generally interpreted as an adaptive metabolic response to chronic illness, accumulating evidence suggests that alterations in thyroid hormone metabolism in CKD may reflect more complex pathophysiological mechanisms, including impaired peripheral deiodination, mitochondrial dysfunction, chronic inflammation, and altered availability of enzymatic cofactors.

In this context, reverse triiodothyronine (rT3), a thyroid hormone metabolite generated through peripheral deiodination of thyroxine (T4), has been proposed as a potential marker of altered thyroid hormone metabolism. Although rT3 is not routinely used in clinical practice, it may provide additional insights into the balance between activating and inactivating pathways of thyroid hormone metabolism, particularly when interpreted in combination with fT3 (e.g., rT3/fT3 ratio).

Recent findings from the REORIENTED study conducted in a well-characterized cohort of patients with autosomal dominant polycystic kidney disease (ADPKD), identified a distinct thyroid hormone profile characterized by increased rT3 levels, reduced fT3 concentrations, and a significant association between both fT3 and rT3 levels and renal function, measured as estimated glomerular filtration rate (eGFR). These relationships were particularly strong in patients with moderate to severe kidney dysfunction, who exhibit an increased rT3/fT3 ratio compared to patients with normal to mild decrease in eGFR, probably due to an increased conversion of T4 into rT3 at the expense of the production of fT3.

These observations raise the hypothesis that ADPKD may be associated with disease-specific alterations in thyroid hormone profile, potentially reflecting unique features of cystic kidney disease. However, it remains unclear whether this hormonal pattern is specific to ADPKD or rather represents a general feature of advanced CKD, independent of the etiology.

To address this question, a comparative analysis with non-ADPKD CKD patients with similar kidney function is required. By leveraging biobank-stored samples and clinical data from well-characterized CKD cohorts, it is possible to investigate whether the alterations observed in ADPKD are also present in other forms of advanced renal disease.

If a similar pattern of increased rT3 and reduced fT3 (or altered rT3/fT3 ratio) is observed in non-ADPKD CKD patients, this would support the hypothesis that these changes primarily reflect reduced kidney function and systemic illness. Conversely, if such alterations are attenuated or absent, this would suggest that ADPKD is characterized by a distinct modulation of thyroid hormone metabolism, supporting a disease-specific pathophysiological mechanism.

In this perspective, the present biobank-based observational comparative study was designed to characterize circulating thyroid hormone profiles in severe non-ADPKD CKD and to compare them with those observed in a matched subset of ADPKD patients from the REORIENTED cohort, with particular emphasis on rT3 and the rT3/fT3 ratio as biomarkers of altered peripheral thyroid hormone metabolism.

In this context, if the observed thyroid hormone alterations are hypothesized to reflect mechanisms related to impaired kidney dysfunction rather than ADPKD itself, the ADAPT cohort-a prospective, randomized, double-blind, crossover, placebo-controlled trial published in 2025, which demonstrated beneficial effects of dapagliflozin on hyperfiltration and proteinuria in non-diabetic patients with advanced CKD-may provide a unique opportunity to further investigate thyroid hormone metabolism in advanced kidney disease. Specifically, the availability of biological samples will enable the assessment of serum and urinary thyroid hormone profiles before and after SGLT2 inhibitor treatment, to explore whether these alterations may be modulated by dapagliflozin.

Type d'étude

Observationnel

Inscription (Estimé)

51

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

    • BG
      • Ranica, BG, Italie, 24020
        • Clinical Research Centre for Rare Diseases Aldo e Cele Daccò

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

  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.

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
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
ADPKD group
A subset of patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) previously enrolled in the REORIENTED clinical study (NCT05646420), will be selected (only if they present the same CKD stage as the non-ADPKD CKD group).
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Serum rT3
Délai: 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.
One single measurement at baseline
Urine rT3
Délai: 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.
One single measurement at baseline
Serum free T3
Délai: 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.
One single measurement at baseline
Serum free T4
Délai: 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
One single measurement at baseline
Serum TSH
Délai: 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
One single measurement at baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chaise d'étude: Giuseppe Remuzzi, M.D., Istituto Di Ricerche Farmacologiche Mario Negri

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 septembre 2027

Achèvement de l'étude (Estimé)

1 septembre 2027

Dates d'inscription aux études

Première soumission

15 juin 2026

Première soumission répondant aux critères de contrôle qualité

18 juin 2026

Première publication (Réel)

23 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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