Abstract: INFO16-TH
Pegcetacoplan for Adults with High Risk of Delayed Graft Function: A Phase 3, Randomized, Placebo-Controlled Trial
Session Information
- Informational Posters - 1
November 06, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Transplantation
- No subcategory defined
Authors
- Khankin, Eliyahu V., Apellis Pharmaceuticals Inc, Waltham, Massachusetts, United States
- Liu, Tzu-Ying, Apellis Pharmaceuticals Inc, Waltham, Massachusetts, United States
- Keshavarz, Ali, Apellis Pharmaceuticals Inc, Waltham, Massachusetts, United States
Description
Background: Delayed graft function (DGF) is characterized by insufficient kidney allograft function immediately after transplantation. In the first year post–transplant, patients with DGF face 3.5 times greater risk of kidney allograft failure than patients without DGF. DGF stems from the inflammation and overactivation of the complement system that occur with ischemic and reperfusion injuries during organ retrieval. Consequently, DGF incidence is higher after transplantation of kidneys from deceased donors than living donors. Pegcetacoplan (PEG), a C3/C3b inhibitor, could address the pathology of DGF by inhibiting complement activity. A phase 3, randomized, placebo-controlled trial (NCT07020832) is planned to test PEG in adults with high DGF risk.
Methods: The study will include dialysis-dependent adults (≥18 years old) with end-stage kidney disease awaiting a first or second transplant with a deceased donor kidney. The trial includes a sentinel portion and a randomized controlled portion (RCP) (Fig 1a). In the sentinel portion, patients receive open-label PEG in 3 sequential groups. Safety data for each patient will be reviewed by the data monitoring committee before RCP enrollment can proceed. In the RCP, patients will be randomized 1:1 to PEG or placebo. In the both portions, PEG or placebo (RCP only) will be dosed at 1080 mg (intravenous [IV] infusion on days 1 [transplant], 2, 3; subcutaneous dosing on days 3 [≥8 hours after IV dose], 5, 7, and 3 times per week thereafter up to day 90), followed by a 40-week follow-up (Fig 1b). The primary endpoint is time to freedom from dialysis through day 90.
Results: Enrollment will begin in September 2025.
Conclusion: The trial will evaluate PEG in kidney transplant recipients at high risk of developing DGF.
Funding
- This study was funded by Apellis Pharmaceuticals, Inc and Sobi (Swedish Orphan Biovitrum AB).