drugset / Trial / NCT02390362
Randomized Trial Comparing Rituximab Against Mycophenolate Mofetil in Children Wtih Refractory Nephrotic Syndrome
Phase 3
Terminated
3 enrolled
Nationwide Children's Hospital
Children's Healthcare of Atlanta · collabEmory University · collabGenentech, Inc. · collabThe NephCure Foundation · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mycophenolate Mofetil | Small molecule | 600 mg/m2 | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |