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Thyroid Hormones in CKD (THYROID-CKD)

18 czerwca 2026 zaktualizowane przez: Mario Negri Institute for Pharmacological Research

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).

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

51

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

  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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Serum rT3
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Krzesło do nauki: Giuseppe Remuzzi, M.D., Istituto Di Ricerche Farmacologiche Mario Negri

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 września 2027

Ukończenie studiów (Szacowany)

1 września 2027

Daty rejestracji na studia

Pierwszy przesłany

15 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

23 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • THYROID-CKD

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .