Transplant Trial Watch

Two-year outcomes in de novo renal transplant recipients receiving everolimus-facilitated calcineurin inhibitor reduction regimen from TRANSFORM study.

Berger, S. P., Sommerer, C. et al. (2019).

American Journal of Transplantation; [record in progress].

This study aimed to assess the two-year outcomes of patients from the TRANSFORM study receiving everolimus (EVR) with reduced‐exposure calcineurin inhibitors (CNI) (EVR+rCNI) vs mycophenolic acid (MPA) with standard‐exposure CNI (MPA+sCNI).

This is a post-hoc analysis of the TRANSFORM (TRANSplant eFficacy and safety Outcomes with an eveRolimus‐based regiMen) trial, which compared the effect of renal transplant recipients receiving everolimus (EVR) with reduced‐exposure calcineurin inhibitor (EVR + rCNI) or mycophenolate with standard‐exposure CNI.

2037 de novo kidney transplant patients from the TRANSFORM study (n=1022 EVR+rCNI; n=1015 MPA+sCNI).

The primary outcome measured was a binary composite of treated biopsy-proven acute rejection (tBPAR) or suboptimal kidney function (eGFR 50 ml/min per 1.73m2) at 24 months post-transplant. The secondary outcome measured was a composite of efficacy failure and included tBPAR, graft loss, or death.

24 months

CET Conclusions
This manuscript reports 24-month follow-up from the TRANSFORM study. 2037 de novo renal transplant recipients were randomized to everolimus and reduced dose CNI, or to MMF and standard-dose CNI. No difference in efficacy was seen, with similar eGFR and BPAR rates in both arms. As might be expected from previous mTORi studies, medication discontinuation due to adverse events was higher in the everolimus arm. However, infection rates, particularly for viral infections, were lower with everolimus. This is a large multicenter study that is well conducted and reported. Whilst it doesn’t offer a compelling reason to use everolimus over a standard Tac/MMF regimen, it certainly supports it as an alternative strategy with equivalent efficacy. Choice of regimen is likely to be dictated by side-effect profile.

Jadad score

Data analysis
Strict intention-to-treat analysis

Allocation concealment

Trial registration - NCT01950819

Funding source
Industry funded