Chronic Kidney Disease (Stages 4 and 5)THYROID-CKDNCT07663773
Thyroid Hormones in CKD
An observational study of Chronic Kidney Disease (Stages 4 and 5), run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (Stages 4 and 5)
- What is being tested?
- Laboratory measurements
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 15Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Clinical Research Centre for Rare Diseases Aldo e Cele Daccò
Ranica, BG, 24020
About this study
Official title: 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).
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease (Stages 4 and 5)
- Being tested
- Laboratory measurements
- Keywords
- Thyroid Hormones, CKD
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory measurementsOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Laboratory measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: One single measurement at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease (Stages 4 and 5)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Remuzzi, M.D., Study chair, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663773
- Sponsor's protocol ID
- THYROID-CKD
- Acronym
- THYROID-CKD
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41141510Vargas 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.
PubMed 16452532den 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.
PubMed 15807872Chonchol 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.
PubMed 18550654Kaptein 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.
PubMed 8641223Rhee 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.
PubMed 24574542Narasaki 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.
PubMed 34140092Carrero 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.
PubMed 17908160Zoccali 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.
PubMed 16775599Lo 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.
PubMed 15698444
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Role of Thyroid Hormones in Severe Non-ADPKD Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07663773
- Acronym / sponsor ID
- THYROID-CKD / THYROID-CKD
- Conditions
- Chronic Kidney Disease (Stages 4 and 5)
- Keywords
- Thyroid Hormones, CKD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-ADPKD CKD group | – | Other: Laboratory measurementsPatients 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. |
| ADPKD group | – | Other: Laboratory measurementsA 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- Non-ADPKD CKD
- ADPKD CKD
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory measurementsReverse 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 | Other | ADPKD group, Non-ADPKD CKD group |
Primary outcome
Serum rT3
Time frame: 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.
Urine rT3
Time frame: 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.
Serum free T3
Time frame: 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.
Serum free T4
Time frame: 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
Serum TSH
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Background: PubMed 41141510Trillini 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.
- Background: PubMed 16452532Vargas 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.
- Background: PubMed 15807872den 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.
- Background: PubMed 18550654Chonchol 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.
- Background: PubMed 8641223Kaptein 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.
- Background: PubMed 24574542Rhee 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.
- Background: PubMed 34140092Narasaki 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.
- Background: PubMed 17908160Carrero 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.
- Background: PubMed 16775599Zoccali 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.
- Background: PubMed 15698444Lo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giuseppe Remuzzi, M.D. study chair
Istituto Di Ricerche Farmacologiche Mario Negri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease (Stages 4 and 5), run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matias Trillini, M.D. (+390354535411, matias.trillini@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum rT3 (time frame: One single measurement at baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07663773, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.