Dapagliflozin With or Without Finerenone for Kidney Disease in Type 2 Diabetes
Compares two treatments for protein in the urine in diabetic kidney disease.
Plain-language title generated from the registry record
Registry title: "Dapagliflozin vs Dapagliflozin-Finerenone for Albuminuria in CKD With Type 2 Diabetes"
Key facts
- Where
- Chittagong, BangladeshSee the site
- Phase
- Phase 3
Where in Bangladesh
- Chittagong medical College hospitalChittagong, BangladeshNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chittagong Medical College
- Trial code
- NCT07598864
- Record updated
- 20 May 2026
- Original description
Chronic kidney disease (CKD) in patients with type 2 diabetes mellitus (T2DM) is a major cause of morbidity, commonly associated with persistent albuminuria and progressive renal decline. Reducing albuminuria is a key therapeutic goal to slow disease progression. Sodium-glucose cotransporter-2 inhibitors like dapagliflozin and non-steroidal mineralocorticoid receptor antagonists such as finerenone have independently shown significant renoprotective effects. Their combined use may provide additive benefits.Read full original descriptionShow less
Effect of Dapagliflozin Compared to Dapagliflozin-finerenone Combination on Albuminuria in Patients With Chronic Kidney Disease and Type 2 Diabetes: A Randomized Controlled Trial.
Chronic kidney disease (CKD) in patients with type 2 diabetes mellitus (T2DM) is a major cause of morbidity, commonly associated with persistent albuminuria and progressive renal decline. Reducing albuminuria is a key therapeutic goal to slow disease progression. Sodium-glucose cotransporter-2 inhibitors like dapagliflozin and non-steroidal mineralocorticoid receptor antagonists such as finerenone have independently shown significant renoprotective effects. Their combined use may provide additive benefits.
This open-label randomized controlled trial will be conducted in the Department of Nephrology, Chittagong Medical College Hospital, Bangladesh, including 88 patients with CKD and T2DM. Participants will be randomized into two groups: one receiving dapagliflozin 10 mg plus finerenone 10 mg daily, and the other receiving dapagliflozin 10 mg alone for eight weeks.
The primary outcome will be the change in urinary albumin-to-creatinine ratio (UACR). Secondary outcomes include serum creatinine, estimated glomerular filtration rate (eGFR), and serum potassium. Safety and adverse events will also be monitored. Data will be analyzed using SPSS version 27.
This study aims to assess whether combination therapy is more effective than dapagliflozin alone in reducing albuminuria and may help guide treatment strategies in diabetic CKD.
Inclusion: Patients aged ≥ 18 years Patients with T2 DM , as defined by the American Diabetic Association. Urinary ACR ≥ 30 mg/g and eGFR ≥ 25 ml/min per 1.73 m2 Prior treatment with ACEIs or ARBs for more than four weeks up to the maximum tolerated dose Serum potassium ≤ 4.8 mmol/L.
Exclusion: Treatment with SGLT2i (empagliflozin:62 hours, dapagliflozin:65hours) or MRAs (finerenone:10-20 hours, spironolactone:7 hours , eplerenone:15-30 hours) within their wash out periods; Known hypersensitivity to dapagliflozin or finerenone; Known case of Addison's disease; Known case of hepatic insufficiency; Glycated hemoglobin (HbA1C) >11%; Patients on non-dihydropyridine Calcium Chanel blockers or Glucagon-like peptide-1 (GLP-1) agonists; Patients with other known causes of proteinuria, e.g. UTI, fever; At screening visit SBP higher than 160 mmHg or DBP higher than 100 mmHg or SBP lower than 90 mmHg; Pregnant lady or lactating mother.