Transplant Trial Watch

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, R., Kainz, A. et al.

Am J Transplant, 2018;[record in progress].


Aims
To determine the long-term effects of anti-inflammatory treatment of organ donors on kidney allograft and patient outcomes.

Interventions
Patients received either 1000mg of methylprednisolone or placebo prior to their organ procurement.

Participants
306 deceased donors and 455 renal transplant recipients from three different transplantation centers in Europe. Of these, 238 patients received an organ from a steroid (methylprednisolone) pretreated donor and 217 patients received an organ from a donor treated with placebo.

Outcomes
The primary outcome was the rate of delayed graft function at one-week. Further primary outcomes included the incidence of acute rejection episodes within the first three months and death censored graft survival at five years. Secondary outcomes measured actual graft survival at five years as well as allograft function over time using the estimated glomerular filtration rate (GFR).

Follow-up
Up to 5 years

CET Conclusions
Steroid pre-treatment of donors has been used to reduce inflammation in donated organs with some supporting evidence from older, non-randomised studies. This report is of a high quality, multi-centre RCT that is well written. The previously reported short-term outcomes from this study found no difference in DGF between the arms, and the study had been powered for that outcome. The authors do present the calculated power for the long-term outcome of graft survival at 5 years, and it is reasonable. The study report shows excellent follow up maintenance at 5 years. The report shows that there was no significant difference in acute rejection at 3 months (10% versus 12%), 5-year graft survival (84% versus 82%), or hazard ratio for graft loss. The use of high-dose systemic steroids prior to organ retrieval is therefore not supported by this study.

Jadad score
5

Data analysis
Per protocol analysis

Allocation concealment
Yes

Trial registration
ISRCTN78828338

Funding source
Industry funded