drugset / Trial / NCT02390362

Randomized Trial Comparing Rituximab Against Mycophenolate Mofetil in Children Wtih Refractory Nephrotic Syndrome

NCT02390362

RandomizedSingle-groupOpen-labelTreatment

Summary

We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective than MMF in maintaining remission in children with frequent relapsing or steroid dependent nephrotic syndrome who have had one relapse while receiving MMF. We will conduct a randomized study comparing two Rituximab infusions and continued MMF treatment. We plan to enroll 64 to have a comparater group of 58 (29 in each arm).

Timeline

Start
2015-01
Primary completion
2016-12-07
Completion
2017-01-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mycophenolate Mofetil Small molecule 600 mg/m2 Oral
Subject Rituximab Monoclonal antibody 375 mg/m2

Indications