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Comparing Medications for Reducing Kidney Damage in Diabetes: A Study on Dapagliflozin Alone and with Eplerenone

Comparative study of albuminuria lowering effect of dapagliflozin and dapagliflozin plus eplerenone in patients with Diabetes mellitus: A parallel group, unblinded randomized controlled trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061952
Enrollment
100
Registered
2024-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: E08-E13- Diabetes mellitus

Interventions

Intervention1: GROUP A - DAPAGLIFLOZIN: DRUG NAME - DAPAGLIFLOZIN DOSE - 10 MG ROUTE - PER ORAL FREQUENCY - ONCE A DAY FOR TOTAL DURATION OF 6 WEEKS Intervention2: GROUP B - DAPAGLIFLOZIN AND EPLERENO

Sponsors

Dr Nikhil Kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: b)Patients having urinary albumin to creatinine ratio (UACR) more than >30mg/mmol.

Exclusion criteria

Exclusion criteria: a)Failure to give consent b)History of serious reactions to dapagliflozin and eplerenone c)Severe renal impairment (eGfr less than 30/ml/min/1.73m2 d)End-stage renal disease (ESRD) e)Patient on dialysis f)Patient having serum potassium >5.5meq/l at initiation g)Concomitant administration of strong cyp3a inhibitors (e.g. ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir and nelfinavir h)Concomitant administration of potassium supplements or potassium-sparing diuretics

Design outcomes

Primary

MeasureTime frame
URINE ALBUMIN TO CREATININE RATIOTimepoint: BASELINE, 6 WEEKS

Secondary

MeasureTime frame
SERUM CREATININETimepoint: AT 0, 6 weeks

Countries

India

Contacts

Public ContactNIKHIL Kumar

Dr. Rajendra Prasad Govt. Medical College & Hospital Tanda H.P.

kapoordhiraj92@gmail.com7018784841

Outcome results

None listed

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