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Comparison of a treatment with Dapagliflozin/Empagliflozin alone vs in combination with Finerenone in delaying progression of CKD and Quality of life

Comparison of Sodium Glucose Cotransporter-2 inhibitors alone and in combination with Non-steroidal Mineralocorticoid Receptor Antagonists in delaying the progression of Chronic Kidney Disease: A Prospective Cohort study - Fine-flozin study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/07/091064
Enrollment
80
Registered
2025-07-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N181- Chronic kidney disease, stage 1 Health Condition 2: N182- Chronic kidney disease, stage 2 (mild) Health Condition 3: N183- Chronic kidney disease, stage 3 (moderate)

Interventions

Intervention1: Nil: Nil

Sponsors

Dr. Mohammad Rafi Shaik
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years or older as of the index date. 2. Patients belonging to all genders. 3. Patients with a diagnosis of chronic kidney disease stages G1, G2, G3A, G3B and A1, and A2 as per KDIGO guidelines, on or up to 12 months before the index date. 4. Patient with serum Potassium less than or equal to 5.2 mEq/L.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing haemodialysis or peritoneal dialysis. 2. Patients who are already on SGLT-2 inhibitors and NSMRA before the index date. 3. Patients treated with new immunosuppressant therapy for new or relapse kidney disease within the last 2 months 4. Patients with known hypersensitivity to SGLT2 inhibitors or NSMRAs 5. Current pregnancy or lactation 6. Known cases of type 1 diabetes mellitus

Design outcomes

Primary

MeasureTime frame
1. To compare the effects of the combination therapy of Non-Steroidal Mineralocorticoid Receptor Antagonists and Sodium Glucose Cotransporter-2 inhibitors in terms of reducing the fall in eGFR (estimated glomerular filtration rate), UPCR (Urine protein to creatinine ratio), and Serum Creatinine to that of Sodium Glucose Cotransporter-2 inhibitor therapy alone, along with the standard care. 2. To evaluate the effects of Sodium Glucose Cotransporter-2 inhibitor alone and in combination with finerenone on Serum Potassium levels Timepoint: Every 3 months for 1 year

Secondary

MeasureTime frame
1. To assess the quality of life and compare the same among the two treatment groups. 2. To compare the frequency of adverse events between the two treatment groups Timepoint: Every 3 months for 1 year

Countries

India

Contacts

Public ContactDr Mohammad Rafi Shaik

Kasturba Medical College, Mangalore

ashok.shenoy@manipal.edu9880530703

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026