2.1. Study population

The study design and randomization of the multicenter study have been described previously.12 In brief, between February 2006 and November 2008, 306 deceased donors from 3 transplantation centers in Europe were randomly assigned to receive corticosteroids or placebo at least 3 hours before organ retrieval. Donors were enrolled by the transplant coordinator. Randomization was done in blocks by 4 and stratified by donor age using a threshold of 50 years. The blinded study drug or placebo was sent to the donor site by the transplant coordinator. No information on comedication during the donor management prior to study enrollment was available. A total of 455 kidney grafts were finally allocated to recipients who were transplanted at the participating study centers: 238 patients received an organ from a steroid‐pretreated donor and 217 patients received an organ from a donor treated with placebo. All kidneys were statically stored in cold preservation solution and none was machine perfused. Primary outcome was the rate of delayed graft function at 1‐week follow‐up.

Recipients received a perioperative steroid bolus of 40 mg of dexamethasone. Steroids were then tapered to a maintenance dose of 5 mg of prednisolone per day over the course of 3 months. Details on induction therapy are stated in Table 1. All patients were started on a calcineurin inhibitor–based immunosuppressive regimen.

Demographics at time of transplantation for steroid treatment and placebo group

To assess long‐term outcomes of steroid pretreatment, we prospectively followed the patients enrolled in the steroid pretreatment trial for 5 years. The CONSORT flow chart is provided in the supplemental data file (Figure S1).

The study protocol was approved by the institutional review board (Ethical Committee of the Medical University of Vienna, Vienna, Austria, EK‐067/2005) and the Eurotransplant kidney advisory committee (6021KAC06) at each study site. All clinical research has been performed in adherence to the Declaration of Helsinki. The clinical and research activities being reported are consistent with the Principles of the Declaration of Istanbul as outlined in the “Declaration of Istanbul on Organ Trafficking and Transplant Tourism.”