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A Phase III, Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropathy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506525-11-00
Acronym
WA41937
Enrollment
52
Registered
2024-03-05
Start date
2021-04-19
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Membranous Nephropathy (pMN)

Brief summary

1. The proportion of patients who achieve a CR at Week 104

Detailed description

1. The proportion of patients who achieve an overall remission at Week 104, 2. The proportion of patients who achieve CR at Week 76, 3. Time to treatment failure, meeting escape criteria, or relapse after complete or partial remission, 4. Time to a sustained reduction of eGFR >= 30% from baseline, 5. Mean change in T-score from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale at Week 104, 6. Duration of CR, 7. Change in anti-PLA2R autoantibody titer from Baseline to Week 52, 8. Mean change from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Assessment of Physical Health scale at Week 104, 9. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, 10. Characterization of adverse events of special interest, 11. Change from baseline in targeted vital signs, 12. Change from baseline in targeted clinical laboratory test results, 13. Serum concentrations of obinutuzumab at specified timepoints, 14. Peripheral B-cell counts at specified timepoints, 15. Prevalence of anti-drug antibodies (ADAs) to obinutuzumab at baseline and incidence of ADAs during the study

Interventions

DRUGGazyvaro 1
DRUG000 mg concentrate for solution for infusion.

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. The proportion of patients who achieve a CR at Week 104

Secondary

MeasureTime frame
1. The proportion of patients who achieve an overall remission at Week 104, 2. The proportion of patients who achieve CR at Week 76, 3. Time to treatment failure, meeting escape criteria, or relapse after complete or partial remission, 4. Time to a sustained reduction of eGFR >= 30% from baseline, 5. Mean change in T-score from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale at Week 104, 6. Duration of CR, 7. Change in anti-PLA2R autoantibody titer from Baseline to Week 52, 8. Mean change from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Assessment of Physical Health scale at Week 104, 9. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, 10. Characterization of adverse events of special interest, 11. Change from baseline in targeted vital signs, 12. Change from baseline in targeted

Countries

France, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026