Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality
Conditions
Interventions
Intervention1: Rituximab: Intravenous rituximab given at 375 mg/m2, 2 doses 1 week apart
Control Intervention1: Tacrolimus: Oral tacrolimus 0.1-0.2 mg/kg/day in 2 divided doses , given for 1 year
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Idiopathic steroid responsive (sensitive) nephrotic syndrome with age 3-18 years Frequently relapsing course with a relapse in the last 3 months Failure of >=2 alternative agents (eg, long term corticosteroids on alternate days, levamisole, oral cyclophosphamide, mycophenolate mofetil (MMF) [Failure of cyclophosphamide defined as occurrence of 2 relapses after 6 months of completing therapy; that for levamisole, long term alternate day steroids and mycophenolate mofetil defined as occurrence of two relapses within last 6 months ; failure of therapy also includes serious therapy-associated adverse effects] Remission confirmed by dipstick Parents willing to give informed written consent
Exclusion criteria
Exclusion criteria: Known secondary cause for nephrotic syndrome (e.g., lupus erythematosus, IgA nephropathy, amyloidosis) rior therapy with cyclosporine or tacrolimus (either drug for >1 week duration)or intravenous rituximab ever Estimated glomerular filtration rate Leukopenia (ANC=126 mg% or HbA1c>=6.1%) at enrolment Known malignancy Previous history of >=1 episode of seizures which are not explained by acute metabolic disturbances(hypoglycemia, hypocalcemia, hyponatremia), hypertension or simple febrile seizures Recent infection requiring hospitalization in the last 3 weeks Patients in whom information regarding disease course and treatment is not available for the last six months Past or present infection with HIV/HBV/HCV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the proportion of patients in sustained remission at 12 months Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in BMI, height and blood pressure standard deviation (SD) scoresTimepoint: 12 months;Frequency of relapses at 6 and 12 monthsTimepoint: 6 and 12 months;Frequency of relapses at 6 and 12 months Timepoint: 12 months;Proportion of children free of corticosteroidsTimepoint: 12 months;The proportion of patients with frequent relapses at 12 months Timepoint: 12 months;The time to first relapseTimepoint: 12 months;Proportion with treatment failure, as defined by occurrence of any of the following: frequent relapses; steroid resistance; toxicity related to corticosteroids or intervention necessitating discontinuation of intervention or change to another agent; two or more serious adverse events related to relapse or interventionTimepoint: 12 months;Therapy associated adverse effects, including obesity, cushingoid habitus, cataract, glaucoma, hirsutism (corticosteroid related); leukopenia, thrombocytopenia, infusion related reactions (fever, chills, rash, bronchospasm, anaphylaxis), acute lung injury (related to rituximab); hyperglycemia, impaired renal function, anemia, seizures, hyperlipidemia, hypertension (related to tacrolimus)Timepoint: 12 months | — |
Countries
India
Contacts
Public ContactAditi Sinha
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed