Health Condition 1: null- Pediatric Idiopathic Nephrotic Syndrome of the Frequently Relapsing and Steroid Dependent Variety
Conditions
Interventions
Intervention1: Daily Levamisole: 2-3 mg/kg/dose once daily for 1 year with interim analysis at 6 months
Control Intervention1: Alternate Day Levamisole: 2-3 mg/kg/dose once every alternate day for 1
Sponsors
Dr Sushmita Banerjee
Dr Apurba Ghosh Institute Director
Eligibility
Inclusion criteria
Inclusion criteria: Patients with Frequently Relapsing or Steroid Dependent Nephrotic Syndrome attending outpatients’ clinic with a relapse. All patients should have normal blood pressure, creatinine, C3 and ANA and be Hep.BsAg. negative.
Exclusion criteria
Exclusion criteria: Secondary nephrotic syndromes, steroid resistant nephrotic syndrome, any active infection, and patients who have received previous therapy with Mycophenolate mofetil, Cyclosporine A or Tacrolimus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of nephrotic syndrome relapses occurring in each groupTimepoint: 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effectsTimepoint: 6 months and 12 months;Extent to which steroid (cumulative dose) could be reduced in subjects in whom they could not be stopped completely.Timepoint: 12 months;Proportion of subjects in each group who can be completely weaned off steroids.Timepoint: 6 months and 12 months | — |
Countries
India
Contacts
Public ContactDr Sushmita Banerjee
Institute of Child Health, Kolkata
Outcome results
None listed