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).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Matias Trillini, M.D.
- 전화번호: +390354535411
- 이메일: matias.trillini@marionegri.it
연구 장소
-
-
BG
-
Ranica, BG, 이탈리아, 24020
- Clinical Research Centre for Rare Diseases Aldo e Cele Daccò
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
- 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.
- 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.
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
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
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Serum rT3
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
수사관
- 연구 의자: Giuseppe Remuzzi, M.D., Istituto Di Ricerche Farmacologiche Mario Negri
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- THYROID-CKD
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .