Randomized Trial of Short‐Course High‐Dose Erythropoietin in Donation After Cardiac Death Kidney Transplant Recipients

• Published in: American journal of transplantation Vol. 12; no. 7; pp. 1793 - 1800
• Main Authors: Aydin, Z., Mallat, M. J. K., Schaapherder, A. F. M., van Zonneveld, A. J., van Kooten, C., Rabelink, T. J., de Fijter, J. W.
• Format: Journal Article
• Language: English
• Published: Malden, USA Blackwell Publishing Inc 01.07.2012; Wiley
• Subjects: Adult; Biological and medical sciences; Death; Delayed graft function; donation after cardiac death; Dose-Response Relationship, Drug; Double-Blind Method; erythropoietin; Erythropoietin - administration & dosage; Female; Humans; Immunosuppressive Agents - administration & dosage; Kidney Transplantation; Male; Medical sciences; Middle Aged; Placebos; randomized trial; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the urinary system; Tissue Donors; Heart; Erythropoietin; Mortality; randomized trial; donation after cardiac death; Homotransplantation; Kidney; Delayed graft function; Randomization; Treatment; Urinary system; Polypeptide; Surgery; Donation; Graft; Clinical trial; Death; Circulatory system; High dose; Kidney transplantation
• ISSN: 1600-6135; 1600-6143
• DOI: 10.1111/j.1600-6143.2012.04019.x

Eryhropoiesis‐stimulating agents have demonstrated tissue‐protective effects in experimental models of ischemia‐reperfusion injury. PROTECT was a 12‐month, randomized, double‐blind, placebo‐controlled, single center study with high‐dose recombinant human erythropoietin‐β (Epoetin) in 92 donation after cardiac death (DCD) kidney transplant recipients. Patients were randomized to receive an intravenous bolus of Epoetin (3.3 × 104 international unit (IU); n = 45) or placebo (saline 0.9% solution; n = 47) on 3 consecutive days, starting 3–4 h before the transplantation and 24 h and 48 h after reperfusion. The immunosuppressive regimen included an anti‐CD25 antibody, steroids, mycophenolate mofetil and delayed introduction of cyclosporine. Primary end point was a composite of the incidence of primary nonfunction and delayed graft function, either defined by spontaneous functional recovery or need for dialysis in the first week. Secondary objectives included duration of delayed function, renal function and proteinuria up to 1 year and thrombotic adverse events. Results showed no differences in the incidence or duration of delayed graft function and/or primary nonfunction (Epoetin 77.8 vs. placebo 78.7%, p = 1.00). Epoetin treatment significantly increased the risk of thrombotic events at 1 month and 1 year (Epoetin 24.4% vs. placebo 6.4%, p = 0.02). This randomized controlled trial with high‐dose epoetin in donation after cardiac death kidney transplant recipients shows no benefit on the incidence and duration of delayed graft function and/or primary nonfunction.