Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3G or IC-MPG: A Multi-Country Study
- Sponsor
- Swedish Orphan Biovitrum
- Study ID
- NCT07746895
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- C3 Glomerulopathy (C3G)
- Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pegcetacoplan — DRUGSolution for infusion for subcutaneous use according to drug use in the real world.
Study Details
The purpose of this study is to evaluate the effectiveness and safety of Pegcetacoplan in patients with C3G and primary IC-MPGN in the real-world setting. This study will also assess biomarkers not routinely measured in clinical practice. Results will support the long-term evaluation of the benefit-risk profile of pegcetacoplan in a broad patient population, informing clinical decision-making.
Key Dates
- First listed
- Aug 5, 2026
- Start date
- Jul 9, 2026
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2031
- Completion
- Jan 31, 2032
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: Single arm
Primary Outcome Measure
Achieving urine protein-to-creatinine ratio (UPCR) of <1 g/g [ Time Frame: at 6 months after starting pegcetacoplan treatment ]
Central Contacts
- Study Physician+46 86972000