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

Idiopathic Membranous Nephropathy Clinical Trial

Official title: A Multicenter Randomized Controlled Trial of Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of Idiopathic Membranous Nephropathy

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

To date, the first-line immunosuppressive therapy of iMN includes corticosteroids combined with cyclophosphamide or Rituximab (RTX) which has been used more and more widely due to superior safety profiles. But the long term remission rate of RTX monotherapy is only 60% and it takes effect relatively slowly.

2 pilot studies reported that the combination therapy of cyclosporine (CsA) and RTX had better efficacy for inducing remission for iMN, with the long term remission rate up to 85%. CsA and RTX may have synergistic effect in the treatment of iMN because they have different time of action and different effects on the immune system and podocytes.

Based on the previous rationale, the investigators designed this trial to determine whether combination of CsA and RTX is more effective than RTX alone in the treatment of iMN. ;

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases

• NCT number: NCT04743739
• Study type: Interventional
• Source: Peking Union Medical College Hospital
• Contact: Sanxi Ai, Doctor
• Phone: 18811054896
• Email: sanxiai@163.com
• Status: Recruiting
• Phase: Phase 3
• Start date: April 14, 2021
• Completion date: March 2025