A trial with dapagliflozin an antidiabetic drug on reducing proteinuria in patients with primary glomerular disorders
- Conditions
- Health Condition 1: N00-N08- Glomerular diseases
- Registration Number
- CTRI/2022/10/046592
- Lead Sponsor
- Institute of post graduate medical education and research kolkata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
1. <18 year of age.
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 < 25
12. Previous therapy with Prednisolone, MMF or alkylating agents within 6 months.
13. AKI
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The primary outcome: Absolute reduction of proteinuria in both armsTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method 2. The secondary outcome: <br/ ><br>a) Cumulative number of patients who experienced remission (both partial and complete remission) on the basis of urine protein analysis. <br/ ><br>b) Change of Estimated glomerular filtration rate (eGFR) during and at the end of therapy. <br/ ><br>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