Diabetic NephropathyPhase 3NCT07598864
"Dapagliflozin vs Dapagliflozin-Finerenone for Albuminuria in CKD With Type 2 Diabetes"
A Phase 3 study testing Dapagliflozin +Finerenone arm and Dapagliflozin arm in people with Diabetic Nephropathy, run by Chittagong Medical College at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Dapagliflozin +Finerenone arm and Dapagliflozin arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 May 2026to 1 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site
Chittagong medical College hospital
Chittagong, 4203
Mohammed Jashim Uddin, MBBS, FCPS, +8802333350180, cmc@ac.dghs.gov.bd
About this study
Official title: 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.
Read more
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.
Read the detailed description
Chronic kidney disease (CKD) is a common and serious complication of type 2 diabetes mellitus (T2DM), contributing significantly to morbidity, mortality, and cardiovascular risk. It often progresses silently and is characterized by persistent albuminuria and declining renal function. Globally, approximately 27% of individuals with T2DM are affected by CKD, with regional variations reflecting differences in healthcare access, comorbidities, and socioeconomic factors. In Bangladesh, the prevalence is notably high, reaching around 34.5% in hospital-based studies, highlighting a major public health concern.
CKD in T2DM is strongly associated with increased cardiovascular morbidity and premature mortality, with cardiovascular disease being the leading cause of death in this population. Despite standard therapies, many patients continue to progress to end-stage kidney disease, emphasizing the need for improved treatment strategies.
Albuminuria is a key marker of glomerular injury and a strong predictor of CKD progression and cardiovascular outcomes. Reduction in urinary albumin-to-creatinine ratio (UACR) is therefore an important therapeutic target and a validated surrogate endpoint in clinical trials. Both sodium-glucose cotransporter-2 inhibitors (SGLT2i) and mineralocorticoid receptor antagonists (MRAs) have demonstrated significant benefits in reducing albuminuria through complementary mechanisms, including improvement of tubuloglomerular feedback and reduction of inflammation and fibrosis.
Dapagliflozin, a selective SGLT2 inhibitor, has shown robust renoprotective and cardioprotective effects, including reduction in albuminuria and slowing CKD progression, as demonstrated in major trials such as DAPA-CKD. Finerenone, a non-steroidal MRA, offers enhanced receptor selectivity with anti-inflammatory and anti-fibrotic effects, along with a lower risk of hyperkalemia compared to traditional MRAs. Large trials such as FIDELIO-DKD and FIGARO-DKD have confirmed its efficacy in reducing renal and cardiovascular outcomes.
Emerging evidence suggests that combining SGLT2 inhibitors with finerenone may provide additive or synergistic benefits, particularly in reducing albuminuria and improving cardiovascular outcomes. Additionally, SGLT2 inhibitors may mitigate the risk of hyperkalemia associated with MRAs, improving the safety profile of combination therapy.
Although current guidelines recommend both drug classes in CKD associated with T2DM, direct comparative evidence between SGLT2 inhibitor monotherapy and combination therapy with finerenone remains limited, especially in South Asian populations. Variations in genetics, diet, and healthcare access further necessitate region-specific research.
This study aims to evaluate the efficacy and safety of dapagliflozin alone versus dapagliflozin combined with finerenone in reducing albuminuria among Bangladeshi patients with CKD and T2DM. The findings may help optimize treatment strategies and improve renal outcomes in this high-risk population.
- Conditions
- Diabetic Nephropathy
- Being tested
- Dapagliflozin +Finerenone arm, Dapagliflozin arm
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin +Finerenone armDrug
Based on the interventions, there will be two groups in the study 1. Experimental group: Dapagliflozin 10 mg plus finerenone 10 mg
Dapagliflozin armDrug
Based on the interventions, there will be two groups in the study Control group : Dapagliflozin 10 mg alon
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Dapagliflozin arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in urinary albumin-to-creatinine ratio from baseline to 8 weeks between the dapagliflozin-finerenone combination group and the dapagliflozin-alone group.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chittagong Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Debasis Roy, Chittagong Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598864
- Sponsor's protocol ID
- 59.127.1557.013.19.2025.1239
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect privacy and consent limits, despite de-identification safeguards
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dapagliflozin Compared to Dapagliflozin-finerenone Combination on Albuminuria in Patients With Chronic Kidney Disease and Type 2 Diabetes: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07598864
- Acronym / sponsor ID
- 59.127.1557.013.19.2025.1239
- Conditions
- Diabetic Nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Chittagong Medical CollegeUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic kidney disease (CKD) is a common and serious complication of type 2 diabetes mellitus (T2DM), contributing significantly to morbidity, mortality, and cardiovascular risk. It often progresses silently and is characterized by persistent albuminuria and declining renal function. Globally, approximately 27% of individuals with T2DM are affected by CKD, with regional variations reflecting differences in healthcare access, comorbidities, and socioeconomic factors. In Bangladesh, the prevalence is notably high, reaching around 34.5% in hospital-based studies, highlighting a major public health concern.
CKD in T2DM is strongly associated with increased cardiovascular morbidity and premature mortality, with cardiovascular disease being the leading cause of death in this population. Despite standard therapies, many patients continue to progress to end-stage kidney disease, emphasizing the need for improved treatment strategies.
Albuminuria is a key marker of glomerular injury and a strong predictor of CKD progression and cardiovascular outcomes. Reduction in urinary albumin-to-creatinine ratio (UACR) is therefore an important therapeutic target and a validated surrogate endpoint in clinical trials. Both sodium-glucose cotransporter-2 inhibitors (SGLT2i) and mineralocorticoid receptor antagonists (MRAs) have demonstrated significant benefits in reducing albuminuria through complementary mechanisms, including improvement of tubuloglomerular feedback and reduction of inflammation and fibrosis.
Dapagliflozin, a selective SGLT2 inhibitor, has shown robust renoprotective and cardioprotective effects, including reduction in albuminuria and slowing CKD progression, as demonstrated in major trials such as DAPA-CKD. Finerenone, a non-steroidal MRA, offers enhanced receptor selectivity with anti-inflammatory and anti-fibrotic effects, along with a lower risk of hyperkalemia compared to traditional MRAs. Large trials such as FIDELIO-DKD and FIGARO-DKD have confirmed its efficacy in reducing renal and cardiovascular outcomes.
Emerging evidence suggests that combining SGLT2 inhibitors with finerenone may provide additive or synergistic benefits, particularly in reducing albuminuria and improving cardiovascular outcomes. Additionally, SGLT2 inhibitors may mitigate the risk of hyperkalemia associated with MRAs, improving the safety profile of combination therapy.
Although current guidelines recommend both drug classes in CKD associated with T2DM, direct comparative evidence between SGLT2 inhibitor monotherapy and combination therapy with finerenone remains limited, especially in South Asian populations. Variations in genetics, diet, and healthcare access further necessitate region-specific research.
This study aims to evaluate the efficacy and safety of dapagliflozin alone versus dapagliflozin combined with finerenone in reducing albuminuria among Bangladeshi patients with CKD and T2DM. The findings may help optimize treatment strategies and improve renal outcomes in this high-risk population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin + Finerenone arm | Experimental | Drug: Dapagliflozin +Finerenone armBased on the interventions, there will be two groups in the study 1. Experimental group: Dapagliflozin 10 mg plus finerenone 10 mg |
| Dapagliflozin arm | Active comparator | Drug: Dapagliflozin armBased on the interventions, there will be two groups in the study Control group : Dapagliflozin 10 mg alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin +Finerenone armBased 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 armBased on the interventions, there will be two groups in the study Control group : Dapagliflozin 10 mg alon | Drug | Dapagliflozin arm |
Primary outcome
change in urinary albumin-to-creatinine ratio from baseline to 8 weeks between the dapagliflozin-finerenone combination group and the dapagliflozin-alone group.
Time frame: 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
4 secondary outcomes
Number of participants with 30% or more eGFR fall from baseline to follow-up
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No. IPD will not be shared to protect privacy and consent limits, despite de-identification safeguards
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin +Finerenone arm and Dapagliflozin arm in people with Diabetic Nephropathy, run by Chittagong Medical College at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debasis Roy, MBBS (+8801737376811, debasisroy2014@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in urinary albumin-to-creatinine ratio from baseline to 8 weeks between the dapagliflozin-finerenone combination group and the dapagliflozin-alone group. (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.