Health Condition 1: N041- Nephrotic syndrome with focal andsegmental glomerular lesions Health Condition 2: N040- Nephrotic syndrome with minor glomerular abnormality
Conditions
Interventions
Intervention1: Oral prednisolone taper over 4 months: After oral prednisolone at 1 mg per kg per day and documented clinical remission, the intervention group will be tapered off oral prednisolone ove
Sponsors
PGIMER Chandigarh
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Hepatitis B, C or human immunodeficiency virus I/II infection, or 2. Prior use of steroids/ immunosuppressive medication within the past 12 months, or 3. Persistent renal dysfunction despite remission of proteinuria � History of Diabetes mellitus (DM) � Abnormal liver function tests � Anti-nuclear antibody positivity, or history of steroid intolerance before randomisation, active urinary sediment ( >5 red blood cells/high-power field in unspun urine), antinuclear antibody positivity, and suspected secondary causes of nephrotic syndrome, drug-induced minimal change disease (e.g., analgesic- or omeprazole-associated).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: Relapse-free remission at the end of 12 months of randomisationTimepoint: Any time point in the first 12 months of study entry | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to relapse, relapse-free remission in the MCD & FSGS subgroups, as well as in treatment-naïve & infrequently relapsing patients, cumulative prednisolone dose, & safety profile.Timepoint: Any time point in the first 12 months of study entry | — |
Countries
India
Contacts
Public ContactJoyita Bharati
PGIMER, Chandigarh
Outcome results
None listed