Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMN

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to determine whether or not cyclosporine (CsA) combined with RTX is more effective than RTX alone in the treatment of idiopathic membranous nephropathy (iMN).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Beijing Tongren Hospital; Chinese Academy of Medical Sciences, Fuwai Hospital; First Affiliated Hospital of Xinjiang Medical University; Nanyang Nanshi Hospital of Henan University; Shanghai Fosun Pharmaceutical Development Co, Ltd.; The Luhe Teaching Hospital of the Capital Medical University; The Seventh Affiliated Hospital of Sun Yat-sen University; The Seventh Affiliated Hospital, Sun Yat-sen University
• Treatments: Cyclosporine; Cyclosporins; Rituximab

Criteria

Inclusion Criteria:

• idiopathic MN with or without diagnostic biopsy

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

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

• Angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for ≥3 months prior to randomization with controlled blood pressure or if patients is intolerant to ACEI/ARB

• proteinuria ≥4g/24h using the average from two 24-hour urine samples collected within 2 weeks of each other, and decreased ≤50% from baseline.

• estimated glomerular filtration rate (eGFR) ≥40ml/min/1.73m2

Exclusion Criteria:

• presence of active infection or a secondary cause of MN

• diabetes mellitus: to exclude proteinuria secondary to diabetic nephropathy.

• pregnancy or breast feeding

• history of resistance to CsA or other calcineurin inhibitors(CNI), RTX or alkylating agents.

• Patients who previously achieved remission after treatment of CNI, RTX or alkylating agents but relapsed off CNI after 3 months, or relapsed off RTX or alkylating agents after 6 months, are eligible.