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.
- Conditions
- Nephrotic Syndrome
- Registration Number
- CTRI/2015/01/005363
- Lead Sponsor
- NRS Medical College and Hospital
- Brief Summary
The vast majority of children with idiopathic nephrotic syndromerespond well to corticosteroid treatment. However, as many as 80% experience a relapse. Repeated and prolongedcourses of steroids in these children often result in long-term complications.The goal of treatment is to reduce the rate of relapses, the cumulative dose ofcorticosteroids, and the incidence of serious complications. In order tominimize the side effects of steroid therapy, different steroid doses andschedules are used. Standard therapy of 1 month alternate day steroid for managingrelapse results in further relapse among50% of children. Various recent reports are suggesting that prolongation ofthis alternate day steroid keeping the cumulative steroid load same, mayproduce better efficacy in preventing further relapses.1-5 Studiescomparing the usefulness of these two schedules are lacking. In our proposed randomized controlled trial, we wantto compare the efficacy and safety of one month vs. two month of alternate dayoral steroid in managing relapse of Idiopathic Steroid Sensitive NephroticSyndrome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 120
Infrequent relapse nephrotic syndrome; No previously intake of any steroid sparing agent; Informed written consent.
Patients with severe leucopenia (leucocytes <3•0× 1000 cells/mm3), severe anemia (haemoglobin <8•9 g/dl), severe thrombocytopenia (platelet <100•0 × 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 months 3,6,9 and 12 month
- Secondary Outcome Measures
Name Time Method number of relapses, cumulative steroid dose 3,6,9 and 12 month
Trial Locations
- Locations (1)
Room No.16, Div. of Pediatric Nephrology and OPD, Dept. of Pediatrics, NRS Medical College
🇮🇳Kolkata, WEST BENGAL, India
Room No.16, Div. of Pediatric Nephrology and OPD, Dept. of Pediatrics, NRS Medical College🇮🇳Kolkata, WEST BENGAL, IndiaBiswanath BasuPrincipal investigatorbasuv3000@gmail.com