Alkaline phosphatase to treat ischemia reperfusion injury in living-donor kidney transplantation - APhIRI I feasibility pilot study.
Steenvoorden, T. S., et al.British Journal of Clinical Pharmacology 2023 [record in progress].
Aims
The aim of this study was to assess the feasibility and safety of alkaline phosphatase for treating ischaemia–reperfusion injury in living donor kidney transplantation.
Interventions
Participants were randomised to either the alkaline phosphatase (bRESCAP) group or the placebo group.
Participants
11 living donor kiney transplant recipients.
Outcomes
The primary endpoint was 1-year graft function. The secondary endpoints included (serious) AEs (SAEs), and urine and serum biomarkers.
Follow-up
1 year posttransplantation
CET Conclusions
This is a small study, albeit randomised. Only 5 patients received the alkaline phosphatase treatment and 6 placebo. Given the prior successful use of alkaline phosphatase in cardiac surgery patients could it not have been used in a larger study here, and therefore have more potential to identify any beneficial impact? The study was also conducted only in live kidney transplantation and therefore the potential impact on any ischeamia-reperfusion injury was relatively minimal. Donation after cardiac death is where any potential benefit lies. As it stands, the study showed no real difference between placebo and alkaline phosphatase. The study drug was safely administered in this small group of recipients.
Data analysis
Strict intention-to-treat analysis
Trial registration
EudraCT - 2017-004737-85