A study to compare the effectiveness of two drugs, one given orally (tacrolimus) and another as injection (rituximab) in preventing disease recurrences (relapses) in children with frequent relapses of nephrotic syndrome, a kidney disease characterized by protein losses in the urine.
- Conditions
- Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality
- Registration Number
- CTRI/2018/11/016342
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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 <60 ml/min/1.73 m2
Leukopenia (ANC<=1500/mm3), thrombocytopenia, deranged liver function tests or hyperglycemia (fasting blood sugar >=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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method