Abstract: PUB226
A Randomized Controlled Trial of Alkaline Phosphatase to Prevent Delayed Graft Function in Kidney Donation After Circulatory Death
Session Information
Category: Transplantation
- 2002 Transplantation: Clinical
Authors
- Tellez Garcia, Juan Miguel, Amsterdam UMC Locatie AMC, Amsterdam, NH, Netherlands
- Kraak, Merel, Amsterdam UMC Locatie AMC, Amsterdam, NH, Netherlands
- Steenvoorden, Thei Sybe, Amsterdam UMC Locatie AMC, Amsterdam, NH, Netherlands
- Heijden, Johan willem Van der, Amsterdam UMC Locatie AMC, Amsterdam, NH, Netherlands
- Bemelman, Frederike J., Amsterdam UMC Locatie AMC, Amsterdam, NH, Netherlands
- Vogt, Liffert, Amsterdam UMC Locatie AMC, Amsterdam, NH, Netherlands
Group or Team Name
- Department of Nephrology of the Amsterdam University Medical Center
Background
Deceased-donor transplantation presents an opportunity to expand the donor pool of kidney grafts. Machine perfusion does not completely prevent ischemia reperfusion injury (IRI) in deceased donor kidney transplantation. Donation after circulatory death (DCD) kidney transplantation specifically, has a high rate of IRI-induced acute kidney injury (IRI-AKI) associated delayed graft function (DGF). Alkaline phosphatase (ALP) has been shown in both preclinical and clinical research to reduce IRI-AKI through the conversion of extracellular adenosine triphosphatase into adenosine, dampening IRI associated renal damage. We are doing a phase 2 RCT where patients undergoing DCD kidney transplantation are treated with either ALP or placebo.
Methods
Phase 2 trial in adult patients (>18 years) undergoing DCD type 3/5 kidney transplantation. Eligible patients are randomized to receive either bRESCAP (bovine derived ALP) or placebo. Patients continuously receive either medication or placebo intravenously for 72 hours. Cumulative incidence of both dialysis DGF (dDGF) and time duration (days) of dDGF between ALP and placebo treated groups will be the primary outcome. Secondary outcomes will be differences in functional DGF (fDGF), cytokine and immune system compartments, and cellular and/or humoral rejection. We are enrolling 70 trial participants based on a power needed to detect a clinically relevant risk reduction of 25% in DGF incidence.
Results
As of 4/26/2026, we have randomized 47 participants out of the estimated 70 inclusions. Out of the 47 included participants, 10 patients have developed dDGF defined as the need for dialysis within the first week excluding single sessions for hyperkalaemia. Table 1 shows the characteristics of the donation after circulatory death.
Conclusion
The trial will be concluded this year with expansion of inclusions to Leiden University Medical Center (LUMC) and the preliminary analysis will be done later this year.
characteristics of the donation after circulatory death
| DCD donor characteristic | N |
| Polytrauma | 5 |
| Cerebrovascular accident | 12 |
| Euthanasia | 19 |
| Circulatory arrest | 8 |
| Rspiratory | 2 |
| Sepsis | 1 |
Funding
- Private Foundation Support