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Clinical trial

A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy

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Last updated:29th Aug 2021
Status: Recruiting
Identifier: NCT04629248
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

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