A clinical trial to study the effect of two different regimens of steroids in patients with nephrotic syndrome
Phase 3
- Conditions
- Health Condition 1: N041- Nephrotic syndrome with focal andsegmental glomerular lesionsHealth Condition 2: N040- Nephrotic syndrome with minor glomerular abnormality
- Registration Number
- CTRI/2021/04/032484
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Adult (18 years to 80 years)
2. Nephrotic syndrome
3. Biopsy proved minimal change disease and/or focal segmental glomerulosclerosis (Light microscopy, Immunofluorescence, and Electron microscopy)
Exclusion Criteria
1. Hepatitis B, C or human immunodeficiency virus I/II infection
2. Prior use of steroids/ immunosuppressive medication within 12 months
3. Persistent renal dysfunction even after remission of proteinuria
ï?ªHistory of Diabetes mellitus (DM)
ï?ªAbnormal liver function tests
ï?ªAnti-nuclear antibody positivity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary: Time to first relapseTimepoint: Any time point in the first 12 months of study entry
- Secondary Outcome Measures
Name Time Method The number of relapses, total prednisolone dose, adverse events: episodes of upper/lower respiratory tract infection, Diabetes mellitus, and quality of life.Timepoint: Any time point in the first 12 months of study entry