"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.
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Debasis Roy, MBBS
- Número de telefone: +8801737376811
- E-mail: debasisroy2014@gmail.com
Locais de estudo
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Chittagong, Bangladesh, 4203
- Chittagong medical College hospital
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Contato:
- Mohammed Jashim Uddin, MBBS, FCPS
- Número de telefone: +8802333350180
- E-mail: cmc@ac.dghs.gov.bd
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Dapagliflozin + Finerenone arm
Based on the interventions, there will be two groups in the study 1.
Experimental group: Dapagliflozin 10 mg plus finerenone 10 mg
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Based on the interventions, there will be two groups in the study 1.
Experimental group: Dapagliflozin 10 mg plus finerenone 10 mg
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Comparador Ativo: Dapagliflozin arm
Based on the interventions, there will be two groups in the study Control group : Dapagliflozin 10 mg alone
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Based on the interventions, there will be two groups in the study Control group : Dapagliflozin 10 mg alon
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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change in urinary albumin-to-creatinine ratio from baseline to 8 weeks between the dapagliflozin-finerenone combination group and the dapagliflozin-alone group.
Prazo: 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
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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
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Number of participants with 30% or more eGFR fall from baseline to follow-up
Prazo: 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
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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
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proportion of patients achieving at least 30% reduction in urinary albumin-to-creatinine ratio from baseline to 8 weeks
Prazo: 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
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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
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frequency and pattern of adverse events from baseline to follow-up
Prazo: 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.
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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.
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Number of participants with hyperkalemia from baseline to follow up
Prazo: 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.
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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.
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Outros números de identificação do estudo
- 59.127.1557.013.19.2025.1239
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