Thyroid Hormones in CKD

NCT07663773 | Not Yet Recruiting

• 1 other identifier: THYROID-CKD
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Kidney Disease (Stages 4 and 5)

Keywords

Thyroid Hormones; CKD

Outcome Measures

Primary Outcomes (5)

• 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.

  One single measurement at baseline

• 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.

  One single measurement at baseline

• 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.

  One single measurement at baseline

• 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

  One single measurement at baseline

• Serum TSH

  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

Study Arms (2)

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.

Other: Laboratory measurements

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).

Other: Laboratory measurements

Interventions

Laboratory measurements OTHER

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; Non-ADPKD CKD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (1)

Clinical Research Centre for Rare Diseases Aldo e Cele Daccò

Ranica, BG, 24020, Italy

Location

Related Publications (10)

• Trillini M, Villa A, Perna A, Peracchi T, Fidone D, Rubis N, Guarinoni C, Martinetti D, Chiappa A, Gamba T, Perticucci E, Gambara V, Rota S, Stucchi N, Carrara F, Remuzzi G, Ruggenenti P; ADAPT Study Group. Randomized Trial of Dapagliflozin in Patients With Nondiabetic Stage 4 CKD. Kidney Int Rep. 2025 Jul 24;10(10):3340-3355. doi: 10.1016/j.ekir.2025.07.020. eCollection 2025 Oct.

  PMID: 41141510 BACKGROUND

• Vargas F, Moreno JM, Rodriguez-Gomez I, Wangensteen R, Osuna A, Alvarez-Guerra M, Garcia-Estan J. Vascular and renal function in experimental thyroid disorders. Eur J Endocrinol. 2006 Feb;154(2):197-212. doi: 10.1530/eje.1.02093.

  PMID: 16452532 BACKGROUND

• den Hollander JG, Wulkan RW, Mantel MJ, Berghout A. Correlation between severity of thyroid dysfunction and renal function. Clin Endocrinol (Oxf). 2005 Apr;62(4):423-7. doi: 10.1111/j.1365-2265.2005.02236.x.

  PMID: 15807872 BACKGROUND

• Chonchol M, Lippi G, Salvagno G, Zoppini G, Muggeo M, Targher G. Prevalence of subclinical hypothyroidism in patients with chronic kidney disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1296-300. doi: 10.2215/CJN.00800208. Epub 2008 Jun 11.

  PMID: 18550654 BACKGROUND

• Kaptein EM. Thyroid hormone metabolism and thyroid diseases in chronic renal failure. Endocr Rev. 1996 Feb;17(1):45-63. doi: 10.1210/edrv-17-1-45.

  PMID: 8641223 BACKGROUND

• Rhee CM, Brent GA, Kovesdy CP, Soldin OP, Nguyen D, Budoff MJ, Brunelli SM, Kalantar-Zadeh K. Thyroid functional disease: an under-recognized cardiovascular risk factor in kidney disease patients. Nephrol Dial Transplant. 2015 May;30(5):724-37. doi: 10.1093/ndt/gfu024. Epub 2014 Feb 25.

  PMID: 24574542 BACKGROUND

• Narasaki Y, Sohn P, Rhee CM. The Interplay Between Thyroid Dysfunction and Kidney Disease. Semin Nephrol. 2021 Mar;41(2):133-143. doi: 10.1016/j.semnephrol.2021.03.008.

  PMID: 34140092 BACKGROUND

• Carrero JJ, Qureshi AR, Axelsson J, Yilmaz MI, Rehnmark S, Witt MR, Barany P, Heimburger O, Suliman ME, Alvestrand A, Lindholm B, Stenvinkel P. Clinical and biochemical implications of low thyroid hormone levels (total and free forms) in euthyroid patients with chronic kidney disease. J Intern Med. 2007 Dec;262(6):690-701. doi: 10.1111/j.1365-2796.2007.01865.x. Epub 2007 Oct 1.

  PMID: 17908160 BACKGROUND

• Zoccali C, Mallamaci F, Tripepi G, Cutrupi S, Pizzini P. Low triiodothyronine and survival in end-stage renal disease. Kidney Int. 2006 Aug;70(3):523-8. doi: 10.1038/sj.ki.5001566. Epub 2006 Jun 14.

  PMID: 16775599 BACKGROUND

• Lo JC, Chertow GM, Go AS, Hsu CY. Increased prevalence of subclinical and clinical hypothyroidism in persons with chronic kidney disease. Kidney Int. 2005 Mar;67(3):1047-52. doi: 10.1111/j.1523-1755.2005.00169.x.

  PMID: 15698444 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine samples from non-ADPKD CKD patients will be retrieved from the certified biobank of the Centro Daccò (Centro di Risorse Biologiche Mario Negri - Biobanca Malattie Rare e Renali), where samples are stored under controlled conditions in accordance with ISO 9001:2015 quality standards. Samples are stored under controlled conditions and are labeled with a unique barcode to ensure traceability while maintaining participant confidentiality. Only authorized personnel have access to the biobank facilities and database systems. For this study, only samples with sufficient volume will be used. Information on storage duration and handling procedures will be considered when interpreting laboratory results. Biological samples will be used exclusively for the purposes described in this protocol and in accordance with the biobank informed consent provided by participants.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Remuzzi, M.D.

  Istituto Di Ricerche Farmacologiche Mario Negri

  STUDY CHAIR

Central Study Contacts

Matias Trillini, M.D.

CONTACT

+390354535411; matias.trillini@marionegri.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)