drugset / Trial / NCT06120673
REmission in Membranous Nephropathy International Trial (REMIT)
RandomizedParallel-groupOpen-labelTreatment
Summary
REMIT is an investigator-initiated, international, multi-centre, prospective, randomised, open-label, parallel-group trial. A total of 224 adult participants with Primary Membranous Nephropathy (PMN) will be recruited from renal units from Australia, New Zealand Canada, Asia, Europe, United Kingdom, and other countries. Participants will be randomised to receive either corticosteroid and cyclophosphamide or obinutuzumab. The primary outcome is a ranked, composite measure based on (a) efficacy, defined as either complete or partial remission of PMN, (b) number of adverse events, and (c) quality of life.
Timeline
- Start
- 2025-10-31
- Primary completion
- 2028-01-31
- Completion
- 2028-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | — | Oral |
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Comparator | Prednisolone | Other / unclassified | 0.5 mg/kg | Oral |