drugset / Trial / NCT06120673

REmission in Membranous Nephropathy International Trial (REMIT)

NCT06120673

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

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified Oral
Subject Obinutuzumab Monoclonal antibody 1000 mg Intravenous
Comparator Prednisolone Other / unclassified 0.5 mg/kg Oral