Health Condition 1: N049- Nephrotic syndrome with unspecified morphologic changes
Conditions
Interventions
Intervention1: Response adjusted therapy protocol: Category I
Group A: Intervention group (Response-adjusted therapy)
Patients shall receive prednisolone therapy at a dose of 40 mg/m2 AD for 2 weeks
G
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Steroid-sensitive nephrotic syndrome diagnosed at least 1 year back Infrequently relapses of nephrotic syndrome in the last one year, while on or not on therapy with a steroid-sparing agent, including mycophenolate mofetil levamisole or calcineurin inhibitor (cyclosporine A or tacrolimus) At least one episode of illness (initial episode or relapse) in the last 2 years that was treated with prednisolone Screened during relapse such that relapse treatment with prednisolone had not been started or was initiated less than or equal to 3 days back in an appropriate dose (2 mg/kg or 60 mg/m2) Treated with prednisolone for relapse in a single daily dose of 60 mg/m2 until remission (day 3 of nil/trace protein) and evaluated on the day of remission or within 2 days afterwards Willing to maintain urine protein records and follow up for 6 months
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| estimate the proportion with sustained remission.Timepoint: 6 months from randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to relapseTimepoint: 6 months from randomization;Number of relapses per patientTimepoint: 6 months from randomization;Frequently relapsing nephrotic syndromeTimepoint: 6 months from randomization;Cumulative dosage of prednisolone (mg/m2)Timepoint: 6 months from randomization;Steroid toxicityTimepoint: 6 months from randomization;HPA axis suppressionTimepoint: 6 weeks from randomization | — |
Countries
India
Contacts
Public ContactAditi Sinha
Department of Pediatrics, AIIMS, New Delhi
Outcome results
None listed