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

ConditionDiabetic Nephropathy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorChittagong Medical College

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 arm

    Drug

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

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Dapagliflozin + Finerenone armExperimental treatment 1 intervention
Group B: Dapagliflozin armActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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
2

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
3

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.
4

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.

Other outcomes

Sponsors and contacts

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Chittagong Medical College

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: