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A trial with dapagliflozin an antidiabetic drug on reducing proteinuria in patients with primary glomerular disorders

COMPARISON OF DAPAGLIFLOZIN VS STANDARD ANTIPROTEINURIC TREATMENT IN PATIENTS WITH PRIMARY GLOMERULAR DISORDERS -AN OPEN LABEL RANDOMISED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046592
Enrollment
64
Registered
2022-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Health Condition 1: N00-N08- Glomerular diseases

Interventions

Intervention1: Dapagliflozin: Patients with primary glomerular disorders on stardard antiproteinuric therapy will be compared with patients on Dapagliflozin plus standard antiproteinuric therapy Contr

Sponsors

Institute of post graduate medical education and research kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Biopsy proven primary glomerular diseases who donot require immunosuppression. 2. Estimated glomerular filtration rate (by CKD-EPI) >25 ml/min/1.73m2 BSA. 3. Persistent proteinuria >1 gram/24 hrs receiving maximum tolerable dose of ARB for last 1 month. 4. No contraindication to any of the medication used in the study.

Exclusion criteria

Exclusion criteria: 1. 2. Diabetes mellitus. 3. Severe disabling or life threatening symptoms related to the nephrotic syndrome. 4. Cresentic GN 5. Lupus nephritis 6. Conditions necessary for the use of immunosuppressant. 7. Hepatitis B/C or human immunodeficiency virus infection, other infection 8. Active Neoplasia. 9. women with pregnancy or lactating women 10. eGFR 12. Previous therapy with Prednisolone, MMF or alkylating agents within 6 months. 13. AKI

Design outcomes

Primary

MeasureTime frame
1. The primary outcome: Absolute reduction of proteinuria in both armsTimepoint: 6 months—

Secondary

MeasureTime frame
2. The secondary outcome: a) Cumulative number of patients who experienced remission (both partial and complete remission) on the basis of urine protein analysis. b) Change of Estimated glomerular filtration rate (eGFR) during and at the end of therapy. c) Adverse effects like- infection (urinary tract or genital tract infection or sepsis) whether any episode of hypoglycaemia, AKI or other serious adverse eventsTimepoint: 6 months—

Countries

India

Contacts

Public ContactDR SOURAV SADHUKHAN

INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH

dratanupal@gmail.com8902412944

Outcome results

None listed

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