A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy
A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy
This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy
Actual Study Start Date: June 25, 2021
Estimated Primary Completion Date: January 9, 2025
Estimated Study Completion Date: June 1, 2028
Arm:
- Experimental: Open Label Treatment: Obinutuzumab
- Active Comparator: Open Label Treatment: Tacrolimus
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 140 |
| Actual Study start date | 25 June 2021 |
| Estimated Study Completion Date | 01 June 2028 |