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To assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Finerenone Group | Experimental | Finerenone Drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finerenone | Drug | To assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Renal Function Decline post finerinone therapy | Progressive worsening of kidney function is defined as a sustained ≥40% reduction in eGFR from baseline, progression to kidney failure (ESKD), or renal death. | From enrollment to the end of treatment at 06 months |
| Number of Participants with Heart Failure (HF) Event post finerinone therapy | Defined as hospitalization for new or worsening heart failure, confirmed by clinical evidence of fluid overload, raised BNP levels and the requirement for intravenous therapy or hemodynamic support. | 6 month |
| eGFR Measurement | Estimated glomerular filtration rate calculated using the CKD-EPI formula, standardized for body surface area (mL/min/1.73 m²). | 06 months |
| Number of Participants with Albuminuria | Measured as urinary albumin-to-creatinine ratio (UACR), with categories of moderately increased (30-300 mg/g) and severely increased (>300 mg/g) albuminuria, per KDIGO classification used in the trial protocols. | 06 months |
| Number of Participants with Hyperkalaemia post treatment | Defined as a serum potassium level >5.5 mmol/L, which served as a safety threshold for dose adjustment or discontinuation in the parent trial data. | 06 months |
| Number of Participants with Cardiovascular (CV) Event post treatment with finerinone therapy | Includes CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure (HHF) - forming the composite cardiovascular outcome measure in the finerenone studies. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Awais Danish, FCPS (Internal Medicine) | Contact | 923037589797 | raoawaisdanish@gmail.com |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 2, 2025 | Dec 9, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C576501 | finerenone |
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| 06 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |