Overview

Different Immunosuppressive Treatment in iMN

Status:
Recruiting
Trial end date:
2027-03-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study is to compare the 24 month remission of different immunosuppressive therapies in the treatment of idiopathic membranous nephropathy (iMN)
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking Union Medical College Hospital
Treatments:
Cyclophosphamide
Prednisone
Rituximab
Criteria
Inclusion Criteria:

- idiopathic membranous nephropathy

- Female, must be post-menopausal, sterile or have effective contraception

- must be off steroid or mycophenolate mofetil for >1 month and alkylating agents for or
RTX> 6 months

- Angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
for ≥ 3 months with controlled blood pressure prior to beginning of immunosuppressive
therapy or if patients are intolerant to ACEI/ARB.

- proteinuria ≥4g/24h and decreased ≤ 50% from baseline

Exclusion Criteria:

- presence of active infection or a secondary cause of membranous nephropathy

- proteinuria associated with diabetic nephropathy

- pregnancy or breast feeding

- history of resistance to rituximab or alkylating agents or corticosteroid

- Patients who previously achieved remission after treatment of rituximab or alkylating
agents but relapsed off rituximab or alkylating agents after 6 months are eligible.