NCT07598864Not yet recruitingPhase 3
"Dapagliflozin vs Dapagliflozin-Finerenone for Albuminuria in CKD With Type 2 Diabetes"
Effect of Dapagliflozin Compared to Dapagliflozin-finerenone Combination on Albuminuria in Patients With Chronic Kidney Disease and Type 2 Diabetes: A Randomized Controlled Trial.
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- First submitted
- 5 May 2026
- Start date
- 1 May 2026
- Primary completion date
- 1 May 2027
- Lead sponsor
- Chittagong Medical College
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT07598864
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 88
- From 1 May 2026 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Known hypersensitivity to dapagliflozin or finerenone
- Known case of Addison's disease
- Known case of hepatic insufficiency
Lab values
- Glycated hemoglobin (HbA1C) \>11%
- Patients on non-dihydropyridine Calcium Chanel blockers or Glucagon-like peptide-1 (GLP-1) agonists
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chittagong medical College hospital Coordinator of this site? Confirm its status | Chittagong | Bangladesh | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.