Chronic kidney disease
Conditions
Interventions
Study sites:
National Hospital of Sri Lanka, National Nephrology Specialized Hospital, Colombo North Teaching Hospital, National Hospital Kandy, Teaching Hospital Kurunegala, Teaching Hospital Perad
these will be specified in the Domain-Specific Appendices (DSAs).
Unblinded access is restricted to:
• Data managers handling randomisation and drug management
• Unblinded statisticians supporting ad
Sponsors
The George Institute for Global Health
Eligibility
Inclusion criteria
Inclusion criteria: Core protocol: Potential participants must satisfy all of the following: 1. Age: ?18 years 2. Gender:both males and females 3. Known chronic kidney disease from any cause (eGFR ?25 mL/min/1.73m2) 4. Currently receiving standard of care treatment according to treating physician 5. Eligible for randomisation in at least one recruiting domain-specific appendix 6. Participant and treating physician are willing and able to perform trial procedures 7. 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 disease, 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.
Exclusion criteria
Exclusion criteria: Core protocol: Potential participants must have none of the following: 1. Currently receiving maintenance dialysis 2. Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months 3. Life expectancy less than 6 months MRA Domain-Specific Appendix: Potential participants must have none of the exclusion criteria in the Core Protocol, and must have none of the following: 1. Recipient of kidney transplant 2. Hyperkalaemia (serum potassium ?5.0 mmol/L) at time of screening 3. Current treatment with Mineralocorticoid Receptor Antagonist (MRA), where the treating physician or patient is not willing to discontinue this medication. If willing to discontinue the MRA, the potential participant must be re-screened after they have been on stable standard of care treatment for 4 weeks without the MRA. 4. Known allergy, intolerance or contraindication to MRAs 5. Current treatment with strong CYP3A4 inhibitors 6. Systolic Blood Pressure <110 mmHg or diastolic BP<55 mmHg without antihypertensive therapy at time of screening 7. Severe hepatic impairment 8. Adrenal insufficiency 9. Currently pregnant or breast feeding, or intending to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chronic eGFR slope The primary outcome is the eGFR slope calculated using eGFR values from randomisation to week 108. eGFR slope measures the rate of eGFR decline. The tool/test used for measurement are eGFR measurements that will be derived using serum creatinine values applied to the CKD-EPI equation. All blood tests will be performed at local laboratories. eGFR values are collected at all study visits. eGFR at randomisation (baseline) is the average of two pre-randomisation values comprising: i. eGFR result from randomisation visit, and ii. eGFR result from the screening visit. The Statistical Analysis Appendix will detail how the eGFR slope is calculated, including how missing data values will be managed. [From randomisation to week 108] | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in albuminuria Change in albuminuria as measured by uACR (or uPCR if uACR unavailable) between randomisation and 24 weeks, measured as a continuous variable [From randomisation to week 24] Change in eGFR eGFR measured using serum creatinine and CKD-EPI equation as per primary outcome methodology [ From randomisation to end of washout] Composite of =40% eGFR decline or kidney failure. Kidney failure (defined as eGFR <15 mL/min/1.73m2 or chronic kidney replacement therapy start) at 108 weeks . (Chronic Kidney replacement therapy refers to either receipt of kidney replacement therapy for more than 3 months or deemed to be chronic kidney replacement therapy by the participant’s treating physician) [ From randomisation to week 108] All-cause mortality at 108 weeks [ 108 weeks] Proportion of participants experiencing one or more cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke) between randomisation and 108 weeks. Definitions follow international criteria with clinical, ECG, biomarker and imaging support [ 108 weeks] Safety and tolerability of treatment - Assessed through reported adverse events, lab test results, vitals and discontinuation [ 108 weeks] Change in quality of life - Using the Quality of Life Impact Survey for Kidney Disease (QDIS-CKD) [at 6-monthly intervals from randomisation to week 108.] | — |
Countries
Australia,India,New Zealand,Spain,Sri Lanka
Contacts
Public ContactDr. Selvarajah Mathu
Consultant Nephrologist
Outcome results
None listed