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.