NCT07663773|Not Yet Recruiting
Thyroid Hormones in CKD
THYROID-CKD
Deciphering the Role of Thyroid Hormones in Severe Non-ADPKD Chronic Kidney Disease
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THYROID-CKD
Deciphering the Role of Thyroid Hormones in Severe Non-ADPKD Chronic Kidney Disease
Sponsor study identifier
observational
51
1 country
1
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 15, 2026
Actual (reported)June 23, 2026
Actual (reported)September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Clinical Research Centre for Rare Diseases Aldo e Cele Daccò
Ranica, BG, 24020, Italy
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.
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.
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.
Giuseppe Remuzzi, M.D.
Istituto Di Ricerche Farmacologiche Mario Negri
First Submitted
June 15, 2026
First Posted
June 23, 2026
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2027
EstimatedOne single measurement at baseline
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 23, 2026
Record last verified: 2026-06
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