July 1-2024. Alloksys anticipates that a treatment with RESCAP® reduces the immediate complications resulting from the kidney transplantation procedure and improves the long-term graft survival.
Introduction
An important determinant of graft survival is ischemia reperfusion injury. Ischemia and sequential reperfusion are inherent consequences of any transplantation procedure, in particular when the transplanted kidney is donated after circulatory death.
Preclinical studies have identified RESCAP® (Alkaline phosphatase) as a possible therapy for ischemia reperfusion injury.
The present AphiRI II study is a follow-up of the AphiRI I study. The AphiRI I study on patients receiving kidneys from living donors was a small study on 11 patients (5 were treated with RESCAP and 6 with placebo. See T.S. Steenvoorden et al, Br J Clin Pharmacol. 2023; 89(12):3629-3636).
Study design
AphiRI II is a placebo-controlled phase IIb study on patients receiving a kdney from a donor after circulatory death. Each group will contain 25 patients.
The RESCAP group will receive 1000 units of this enzyme as a bolus at the start of the surgery, and 9000 units via infusion over 24 hours thereafter.
The principle investigator of the study is prof. Liffert Vogt of the Amsterdam University Medical Center (AMS-UMC, The Netherlands). Coordinating investigator is Juan Miguel Tellez Garcia. (AMS-UMC).
It is expected that the study will be finished in 2027.
