A study to compare effectiveness for preventing disease recurrence and safety regarding drug related side effects between a newer-safe drug(Rituximab) and conventionally used drug(Calcineurin Inhibitors)in children with difficult to treat nephrotic syndrome, a chronic protein loosing kidney disease.
- Conditions
- Nephrotic Syndrome
- Registration Number
- CTRI/2014/01/004355
- Lead Sponsor
- NRS Medical College and Hospital
- Brief Summary
Nephrotic syndrome in children is primarily caused by minimal change disease. Majority of these patients respond well to corticosteroids. However, as many as 70% of children with nephrotic syndrome experience at least one relapse, and 30% develop a more complicated course with frequent relapses (FRNS)(≥2 relapses/ 6 months) with or without steroid dependency (SDNS)(relapse during tapering or within 2 weeks after discontinuation of corticosteroids). Repeated and prolonged courses of steroids in these children often result in long-term complications. The goal of the treatment is to reduce the rate of relapses, the cumulative dose of corticosteroids, and the incidence of serious complications. In order to minimize the side effects of steroid therapy, different steroid sparing agents such as cyclophosphamide, calcineurin inhibitors(CNI), levamisole, and mycophenolate mofetil (MMF) have been used in FRNS. Whereas CNI are usually considered the steroid sparing drug class of first choice, rituximab is increasingly used as alternative to minimize CNI toxicity. Various prospective studies suggest that Rituximab, a B cell depleting monoclonal antibody, could be a safe and effective alternative to steroid or immunosuppressants to achieve and maintain remission in this population.Single rituximab infusion have been shown to be efficacious for 6 to 12 months and the side effect profile observed to date is very benign. Studies comparing the usefulness of these agents are lacking. In our proposed randomized controlled trial, we want to compare the efficacy and safety of CNI to that of Rituximab in treating children with FRNS and SDNS. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 60
- Children between 3 and 16 years with SDNS Minimal Change disease/ FSGS/MesPGN as per Kidney Biopsy report.
- Estimated glomerular filtration rate(eGFR) more than 80 ml/min per 1.73 m2 at study entry.
- Remission at study entry (trace or nil proteinuria, as determined by the dipstick test or less than 100 mg/dl for at least 3 days).
- Not received any steroid sparing agent previously.
- Parents willing to give informed written and audiovisual consent.
- Ability to swallow tablet.
- Known etiology (e.g., lupus erythematosus, IgA nephropathy, amyloidosis, malignancy, other secondary forms of NS) Patients with severe leucopenia (leucocytes less than 3.0× 1000 cells/mm3), severe anemia (haemoglobin less than 8.9 g/dl), thrombocytopenia (platelet less than 100.0 × 1000 cells/mm3) or deranged liver function tests (AST or ALT to more than 50 IU/L ) at enrolment.
- Known active chronic infection (tuberculosis, HIV, hepatitis B or C).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 12-month relapse-free survival 12
- Secondary Outcome Measures
Name Time Method eGFR at 3, 6, 9 and 12 months, respectively. Amount of cumulative prednisolone requirement (mg/kg/yr) over 12 months
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 investigator9231236001basuv3000@gmail.com