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Trials - SLCTR/2025/037

Protocol Change

Date

2026-08-05


Protocol

Protocol changed


Item Changed

Inclusion criteria


Previous Version

Core protocol: Potential participants must satisfy all of the following: 1. Age >= 18 years 2. Known chronic kidney disease from any cause (eGFR >=25 mL/min/1.73m2) 3. Currently receiving standard of care treatment according to treating physician 4. Eligible for randomisation in at least one recruiting domain-specific appendix 5. Participant and treating physician are willing and able to perform trial procedures 6. Provision of written informed consent or eConsent prior to performing any protocol related procedures MRA Domain-Specific Appendix: Potential participants must satisfy all of the inclusion criteria in the Core Protocol, and also satisfy the following: 1. Urine albumin-creatinine ratio (uACR) >200 mg/g (22.6 mg/mmol) or urine protein-creatinine ratio (uPCR) >300 mg/g (33.9 mg/mmol) from the most recent result in the previous 3 months. 2. On a stable standard of care treatment for chronic kidney diseaseCKD, including a SGLT2i unless there is a documented reason not to be using a SGLT2i*, for 4 weeks before screening according to treating physician. 3. Treating physician believes finerenone is clinically appropriate for the participant. 4. Participant and treating physician are willing and able to perform MRA DSA procedures. 5. Provision of written informed consent or eConsent prior to performing any MRA DSA related procedures. *Potential reasons for not using a SGLT2i could include intolerance (including allergy or absolute contraindication), cost or inaccessibility (including unavailability), participant refusal or physician decision.


Next Version

Core protocol: Potential participants must satisfy all of the following: 1. Age >= 18 years 2. Known chronic kidney disease from any cause (eGFR >=25 mL/min/1.73m2) 3. Currently receiving standard of care treatment according to treating physician 4. Eligible for randomisation in at least one recruiting domain-specific appendix 5. Participant and treating physician are willing and able to perform trial procedures 6. Provision of written informed consent or eConsent following a fully informed discussion and prior to performing any protocol related procedures MRA Domain-Specific Appendix: Potential participants must satisfy all of the inclusion criteria in the Core Protocol, and also satisfy the following: 1. Urine albumin-creatinine ratio (uACR) >200 mg/g (22.6 mg/mmol) or urine protein-creatinine ratio (uPCR) >300 mg/g (33.9 mg/mmol) at time of screening. 2. On a stable standard of care treatment for CKD, including a SGLT2i unless there is a documented reason not to be using a SGLT2i, for 4 weeks before screening according to treating physician. 3. Treating physician believes finerenone is clinically appropriate for the participant. 4. Participant and treating physician are willing and able to perform MRA DSA procedures. 5. Provision of written informed consent or eConsent following a fully informed discussion and prior to performing any MRA DSA related procedures