Compare Efficacy and Safety of Repeated Courses of Rituximab to That of Maintenance Mycophenolate Mofetil Following Single Course of Rituximab Among Children With Steroid Dependent Nephrotic Syndrome

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the RITURNS II study is to evaluate the efficacy and safety of Repeat courses of Rituximab to that of maintenance Mycophenolate Mofetil following single course of Rituximab in maintaining remission over 24 months among Children with Steroid Dependent Nephrotic Syndrome (SDNS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nilratan Sircar Medical College
• Collaborator: Heidelberg University
• Treatments: Mycophenolic Acid; Rituximab

Criteria

Inclusion Criteria

• Children between 3 and 16 years with SDNS.

• Minimal Change disease/ FSGS/MesPGN as per Kidney Biopsy report.

• Estimated glomerular filtration rate (eGFR) >80 ml/min per 1.73 m2 at study entry.

• Remission at study entry (Urine albumin nil or trace (or proteinuria <4 mg/m2/h) for 3 consecutive early morning specimens).

• Not received any steroid sparing agent previously.

• Parents willing to give informed written and audiovisual consent.

• Ability to swallow tablet.

Exclusion Criteria

• Known etiology (e.g., lupus erythematosus, IgA nephropathy, amyloidosis, malignancy, other secondary forms of NS).

• Patients with severe leukopenia (leukocytes <3.0× 1000 cells/mm3), severe anemia (haemoglobin <8.9 g/dl), thrombocytopenia (platelet <100.0 × 1000 cells/mm3) or deranged liver function tests (AST or ALT to >50 IU/L ) at enrolment.

• Known active chronic infection (tuberculosis, HIV, hepatitis B or C).

• Live vaccination within one month prior to screening.