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

Conditions

• Idiopathic Membranous Nephropathy

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  Rituximab 1000mg, I.V. on Days 1 and 181, and will be retreated or not at Days 15 and 195 according to the CD19+ B cell count.
• cyclosporine — DRUG
  cyclosporine (CsA) will be started at a dose of 3mg/kg/d and adjusted according to the blood levels of the CsA. CsA will be tapered after 6 months and discontinued over a three month period.

Study Details

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).

Key Dates

Start date

Apr 14, 2021

Status verified

Dec 2025

Primary completion

Dec 20, 2022

Completion

Dec 20, 2024

Study Design

Enrollment

12 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Rituximab monotherapy
  Rituximab 1000mg I.V. on Days 1 and 181, and will be retreated or not on Days 15 and 195 according to the CD19+ B cells count.
• Experimental: Rituximab combined with cyclosporine
  Rituximab 1000mg I.V. on Days 1 and 181, and will be retreated or not on Days 15 and 195 according to CD19+ B cells count. cyclosporine (CsA) will be started at a dose of 3mg/kg/day p.o. divided into 2 equal doses given at 12 hour intervals. Doses of CsA will be adjusted according to the blood levels of CsA. CsA will be tapered after 6 months and discontinued over a 3 month period.

Primary Outcome Measure

complete remission (CR) or partial remission (PR) at 24 month [ Time Frame: 24 months after randomization ]