A study to compare effectiveness for preventing disease recurrence and safety regarding drug related side effects between one month vs. two month of alternate day oral steroid in children with nephrotic syndrome, a chronic protein losing kidney disease.
Phase 3
Recruiting
- Conditions
- Health Condition 1: null- Nephrotic Syndrome
- Registration Number
- CTRI/2015/01/005363
- Lead Sponsor
- RS Medical College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Infrequent relapse nephrotic syndrome; No previously intake of any steroid sparing agent; Informed written consent.
Exclusion Criteria
Patients with severe leucopenia (leucocytes <3•0Ã? 1000 cells/mm3), severe anemia (haemoglobin <8•9 g/dl), severe thrombocytopenia (platelet <100•0 Ã? 1000 cells/mm3), deranged liver function tests (AST or ALT to >50 IU/L), or any active infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method sustained remission at 12 monthsTimepoint: 3,6,9 and 12 month
- Secondary Outcome Measures
Name Time Method number of relapses, cumulative steroid doseTimepoint: 3,6,9 and 12 month