Trial results for pegcetacoplan in patients with post-transplant recurrence of C3G or IC-MPGN were posted on ClinicalTrials.gov on 2025-02-07. The study observed that up to 66.7% of participants in one group showed a reduction in C3c staining on renal biopsy at Week 52.
Background
Pegcetacoplan is being investigated for its potential role in treating complement-mediated kidney diseases. This trial specifically addresses patients experiencing recurrence of Complement 3 Glomerulopathy (C3G) or Immune Complex-Mediated Membranoproliferative Glomerulonephritis (IC-MPGN) after a renal transplant, conditions often characterized by complement system dysregulation.
Trial design
This completed Phase 2, multicenter, open-label, randomized, controlled study (NCT04572854) was designed to evaluate the safety and efficacy of pegcetacoplan. The trial enrolled 13 participants diagnosed with C3G or IC-MPGN following a renal transplant. The study aimed to assess the impact of pegcetacoplan on disease markers in this patient population.
Key results
The trial measured the percentage of subjects with a reduction in C3c staining on renal biopsy at various time points:
- At Week 12, in the controlled portion of the study, 50.0% of subjects in Group 1 showed a reduction in C3c staining.
- Also at Week 12, in the controlled portion, 33.3% of subjects in Group 2 showed a reduction in C3c staining.
- At Week 52, in the non-controlled portion, 50.0% of subjects in Group 1 showed a reduction in C3c staining.
- At Week 52, in the non-controlled portion, 66.7% of subjects in Group 2 showed a reduction in C3c staining.
What this means
The results suggest that pegcetacoplan may lead to a reduction in C3c staining in patients with post-transplant recurrence of C3G or IC-MPGN. The observed percentages of reduction in C3c staining, reaching up to 66.7% at Week 52 in one group, indicate a potential biological effect. These findings from a Phase 2 study with a limited enrollment of 13 participants warrant further investigation in larger clinical trials to confirm efficacy and safety.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04572854, titled "Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN," were posted on 2025-02-07 on clinicaltrials.gov.