"Dapagliflozin vs Dapagliflozin-Finerenone for Albuminuria in CKD With Type 2 Diabetes"

NCT07598864 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 59.127.1557.013.19.2025.1239
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

• change in urinary albumin-to-creatinine ratio from baseline to 8 weeks between the dapagliflozin-finerenone combination group and the dapagliflozin-alone group.

  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

Secondary Outcomes (4)

• Number of participants with 30% or more eGFR fall from baseline to follow-up

  eGFR is measured at baseline, 4 weeks, and 8 weeks in dapagliflozin-finerenone combination group and the dapagliflozin-alone group and number of paricipants with 30%or more eGFR fall is measured in both groups and between groups

• proportion of patients achieving at least 30% reduction in urinary albumin-to-creatinine ratio from baseline to 8 weeks

  urinary albumin-to-creatinine ratio reduction is measured at 4 weeks & 8 weeks in the dapagliflozin-finerenone combination group and the dapagliflozin-alone group and change of urinary albumin-to-creatinine ratio reduction is between group

• frequency and pattern of adverse events from baseline to follow-up

  adverse events are evaluated at 4 weeks and 8 weeks in the dapagliflozin-finerenone combination group and the dapagliflozin-alone group and and compare between groups.

• Number of participants with hyperkalemia from baseline to follow up

  Serum potassium is measured at baseline, 4 weeks and 8 weeks in dapagliflozin group and dapagliflozin- finerenone combination group, and number of participants with hyperkalemia is measured in both groups and between groups.

Study Arms (2)

Dapagliflozin + Finerenone arm

EXPERIMENTAL

Based on the interventions, there will be two groups in the study 1. Experimental group: Dapagliflozin 10 mg plus finerenone 10 mg

Drug: Dapagliflozin +Finerenone arm

Dapagliflozin arm

ACTIVE COMPARATOR

Based on the interventions, there will be two groups in the study Control group : Dapagliflozin 10 mg alone

Drug: Dapagliflozin arm

Interventions

Dapagliflozin +Finerenone arm DRUG

Based on the interventions, there will be two groups in the study 1. Experimental group: Dapagliflozin 10 mg plus finerenone 10 mg

Dapagliflozin + Finerenone arm

Dapagliflozin arm DRUG

Based on the interventions, there will be two groups in the study Control group : Dapagliflozin 10 mg alon

Dapagliflozin arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chittagong Medical College: lead

Study Sites (1)

Chittagong medical College hospital

Chittagong, 4203, Bangladesh

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Debasis Roy, MBBS

CONTACT

+8801737376811; debasisroy2014@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Resident

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)