drugset / Trial / NCT03298698

Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome

NCT03298698 ↗

Phase 3 Unknown 40 enrolled Radboud University Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

This will be an open-label, randomized controlled trial which compares continued treatment with high dose prednisone (standard therapy) to treatment with rituximab in patients with minimal change disease or focal segmental glomerulosclerosis unresponsive to 8 weeks of high dose prednisone . patients either receive 2 doses of Rituximab 375 mg/m2 iv at time 0 and 14 days with termination of prednisone or standard therapy which consist of 8 additional weeks of high dose prednisone treatment.

Timeline

Start
2018-08-22
Primary completion
2021-08-22
Completion
2022-01-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Prednisone Other / unclassified 1 mg/kg —
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous