Steroid pretreatment of organ donors does not impact on early rejection and long-term kidney allograft survival: Results from a multicenter randomized, controlled trial

Roman Reindl-Schwaighofer, Alexander Kainz, Kira Jelencsics, Andreas Heinzel, Gabriela Berlakovich, A. Remport, Georg Heinze, R. Langer, Rainer Oberbauer

Research output: Contribution to journalArticle

Abstract

Steroid pretreatment of deceased donors reduces inflammation in allografts and is recommended by organ procurement guidelines. The impact on long-term graft outcome, however, remains elusive. In this multicenter randomized controlled trial, 306 deceased donors providing organs for 455 renal transplant recipients were randomized to 1000 mg of methylprednisolone or placebo prior to organ procurement (ISRCTN78828338). The incidence of biopsy-confirmed rejection (Banff>1) at 3 months was 23 (10%) in the steroid group and 26 (12%) in the placebo group (P =.468). Five-year functional graft survival was 84% and 82% for the steroid group and placebo group, respectively (P-value =.941). The hazard ratio of functional graft loss was 0.90 (95% confidence interval 0.57-1.42, P =.638) for steroid vs placebo in a multivariate Cox model. We did not observe effect modification by any of the predictors of graft survival and treatment modality. A robust sandwich estimate was used to account for paired grafts of some donors. The mean estimated GFR at 5 years was 47 mL/min per 1.73 m2 in the steroid group and 48 mL/min per 1.73 m2 in the placebo group (P =.756). We conclude that steroid pretreatment does not impact on long-term graft survival. In a donor population with higher risk of delayed graft function, however, repetitive and higher doses of steroid treatment may result in different findings.

Original languageEnglish
JournalAmerican Journal of Transplantation
DOIs
Publication statusPublished - Jan 1 2019

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Allografts
Randomized Controlled Trials
Steroids
Tissue Donors
Kidney
Placebos
Graft Survival
Tissue and Organ Procurement
Transplants
Delayed Graft Function
Methylprednisolone
Proportional Hazards Models
Guidelines
Confidence Intervals
Inflammation
Biopsy
Incidence
Therapeutics
Population

Keywords

  • clinical trial
  • critical care/intensive care management
  • donors and donation: deceased
  • graft survival
  • kidney transplantation/nephrology
  • organ procurement and allocation
  • translational research/science

ASJC Scopus subject areas

  • Immunology and Allergy
  • Transplantation
  • Pharmacology (medical)

Cite this

Steroid pretreatment of organ donors does not impact on early rejection and long-term kidney allograft survival : Results from a multicenter randomized, controlled trial. / Reindl-Schwaighofer, Roman; Kainz, Alexander; Jelencsics, Kira; Heinzel, Andreas; Berlakovich, Gabriela; Remport, A.; Heinze, Georg; Langer, R.; Oberbauer, Rainer.

In: American Journal of Transplantation, 01.01.2019.

Research output: Contribution to journalArticle

Reindl-Schwaighofer, Roman ; Kainz, Alexander ; Jelencsics, Kira ; Heinzel, Andreas ; Berlakovich, Gabriela ; Remport, A. ; Heinze, Georg ; Langer, R. ; Oberbauer, Rainer. / Steroid pretreatment of organ donors does not impact on early rejection and long-term kidney allograft survival : Results from a multicenter randomized, controlled trial. In: American Journal of Transplantation. 2019.
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