Franny Jongbloed

216 CHAPTER 8 This study has several limitations. It was designed as a pilot study in a single transplantation center, therefore only a small cohort of patients was included and no power calculations were performed. Replacement of donor-recipient pairs that were excluded from the waiting list for various reasons (Figure S1) was performed until the desired number of 15 donors in the CCPR group was reached. As a result, the number of donors included in the control group was higher. In addition, expression analysis was only performed at mRNA level. Investigating the effects of CCPR in a larger cohort, in a different surgical population, and on a posttranscriptional level might underscore its clinical potential as well as reveal the mechanisms by which short-term DR acts in humans. Two patients received the immunosuppressive agent belatacept rather than Tac after inclusion and randomization. These patients developed acute rejection, and were excluded from the study after their rejected kidney was removed. A significantly higher number of female than male donors was included due to the difference in willingness to donate between men and women that has been described earlier 34 . Future studies should strive for inclusion of equal numbers of both sexes. In conclusion, we show that a CCPR diet given during five days immediately before kidney donation accelerates adaptation of kidney function of the remaining kidney and increases resistance to IRI in human kidney transplantation as evidenced by a more rapid recovery of kidney transplant function. On a transcriptional level, hints towards a switch from growth to maintenance and increased stress resistance were found. Given its non-invasive character and safety, our CCPR diet may have great impact on increasing resistance to surgical-related stress in humans. SUBJECTS AND METHODS Study design This pilot study was designed as a randomized, controlled trial and was approved by the Medical Ethics Committee (METC, MEC number 2012-134) of the Erasmus MC, University Medical Center Rotterdam, The Netherlands. The study procedures were in accordance with the local METC guidelines. All subjects provided written informed consent before inclusion. The trial was registered on October 12, 2012 in the Dutch trial registry under trial code 3663 (www.trialregister.nl) . This manuscript was prepared in accordance with the CONSORT 2010 statement 35 .