"Dapagliflozin vs Dapagliflozin-Finerenone for Albuminuria in CKD With Type 2 Diabetes" (NCT07598864) | Clinical Trial Compass
Not Yet RecruitingPhase 3
"Dapagliflozin vs Dapagliflozin-Finerenone for Albuminuria in CKD With Type 2 Diabetes"
Bangladesh88 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
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 criteria
* 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
* Glycated hemoglobin (HbA1C) \>11%
* Known hypersensitivity to dapagliflozin or finerenone
* Known case of Addison's disease
* Known case of hepatic insufficiency
* 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.
* Patients on non-dihydropyridine Calcium Chanel blockers or Glucagon-like peptide-1 (GLP-1) agonists
* Pregnant lady or lactating mother
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares dapagliflozin alone to dapagliflozin combined with finerenone for reducing protein in the urine over just 8 weeks — does that short timeframe tell us enough about long-term kidney protection, or would a longer established treatment be a better starting point for me?
2Since this trial is Phase 3 and hasn't started recruiting yet, how much is already known about the safety of combining dapagliflozin and finerenone together, and are there risks I should understand before considering this combination?
3The main thing this trial is measuring is the change in urinary albumin-to-creatinine ratio — can you explain what that means for my kidneys specifically, and how significant a change in that number would actually be for my health?
4Because this study isn't recruiting yet, there's no guarantee it will open on a timeline that works for me — in the meantime, should I be starting either dapagliflozin or finerenone now as standard care, rather than waiting to see if this trial becomes available?
5Both drugs in this trial are already approved separately — so is there something a clinical trial would offer me that I couldn't get through standard treatment with one or both of these medications outside of a study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in urinary albumin-to-creatinine ratio from baseline to 8 weeks between the dapagliflozin-finerenone combination group and the dapagliflozin-alone group.
Timeframe: urinary albumin-to-creatinine ratio is measured at baseline, 4 weeks and 8 weeks in the dapagliflozin-finerenone combination group and the dapagliflozin-alone groups and between groups