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).
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Matias Trillini, M.D.
- 电话号码:+390354535411
- 邮箱:matias.trillini@marionegri.it
学习地点
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BG
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Ranica、BG、意大利、24020
- Clinical Research Centre for Rare Diseases Aldo e Cele Daccò
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
- 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.
描述
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)
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
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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
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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).
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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
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Serum rT3
大体时间:One single measurement at baseline
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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.
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One single measurement at baseline
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Urine rT3
大体时间:One single measurement at baseline
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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.
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One single measurement at baseline
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Serum free T3
大体时间:One single measurement at baseline
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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.
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One single measurement at baseline
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Serum free T4
大体时间:One single measurement at baseline
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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
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One single measurement at baseline
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Serum TSH
大体时间:One single measurement at baseline
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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
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One single measurement at baseline
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合作者和调查者
调查人员
- 学习椅:Giuseppe Remuzzi, M.D.、Istituto Di Ricerche Farmacologiche Mario Negri
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- THYROID-CKD
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
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