REmission in Membranous Nephropathy International Trial (REMIT)

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

224

Participants

Timeline

Start Date

July 31, 2024

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2028

Conditions
Primary Membranous Nephropathy
Interventions
DRUG

Obinutuzumab

"Participants will receive an intravenous infusion of 1,000mg Obinutuzumab at Weeks 0, 2, 24 and 26.~Prior to the administration of obinutuzumab, the participant will receive pre-medications consisting of all three:~* IV methylprednisolone 80 mg,~* Paracetamol 1,000 mg orally,~* Either cetirizine 10 mg orally or diphenhydramine 50 mg orally. These pre-medications must be completed between 30 to 60 minutes prior to the obinutuzumab infusion."

DRUG

Oral prednisolone and cyclophosphamide

"Participants will receive a combination of oral prednisolone and cyclophosphamide with 2 options (Option A and B).~Option A: Cyclical prednisolone and cyclophosphamide with IV methylprednisolone~* IV methylprednisolone 500-1000 mg will be given on days 1, 2 and 3 at the start of months 1, 3, and 5.~* Oral prednisolone will be given at 0.5 mg/kg/day (max 50 mg/day) in months 1, 3, and 5.~* Oral cyclophosphamide will be given in months 2, 4 and 6, adjusted by age and weight~Option B: Concurrent prednisolone and cyclophosphamide without IV methylprednisolone~* Oral prednisolone will be given to meet a cumulative dose equivalent to 0.5 mg/kg/day for 90 days (max 50 mg/day).~* Oral cyclophosphamide will be given for 90 days, adjusted by age and weight"

Trial Locations (13)

Unknown

Canberra Hospital, Garran

Royal Prince Alfred Hospital, Camperdown

Sunshine Coast University Hospital, Birtinya

Royal Brisbane and Women's Hospital, Brisbane

Bundaberg Hospital, Bundaberg

Cairns Hospital, Cairns

Logan Hospital, Logan City

Mackay Base Hospital, Mackay

Rockhampton Hospital, Rockhampton

Mater Hospital, South Brisbane

Princess Alexandra Hospital, Woolloongabba

Royal Hobart Hospital, Hobart

Fiona Stanley Hospital, Murdoch

All Listed Sponsors
collaborator

University of Adelaide

OTHER

lead

The University of Queensland

OTHER