Background: Delayed graft function (DGF) contributes to higher risk of rejection, poorer graft survival, hospital length of stay (LOS), and other morbidities. Studies also suggest increased risk of rejection with calcineurin-inhbitor (CNI) avoidance. Purpose: To determine if avoidance of CNI and mTOR-inhibitor (mTORi) will improve rate of recovery from DGF. Methods: At our center, renal transplant recipients typically undergo T-cell depletion with ATG, and rapid 4-5 day steroid taper with cyclosporine (CyA) and mTORi maintenance. Patients with DGF are typically managed by 1) changing CyA or mTORi to mycophenolate (MPA) or 2) reduce target level of CyA or mTORi. Prior rates for DGF ranged from 15-20%. We designed a single-center, IND-approved prospective randomized (2:1) pilot study to compare time to recovery from DGF in renal transplant recipients changed to (Treatment)MPA/steroid/Belatacept vs those (Control) maintained on CNI and or mTORi-based maintenance immune suppression. Exclusions: multiple organ recipients, age <18/>65, EBV seronegative status, >12 days post-transplant before enrollment, anti-CD20 or anti-C5 therapy, biopsy proven rejection before enrollment. DGF was defined by need for dialysis < 7 days post-transplant or estimated glomerular filtration rate eGFR< 20 by day 5 post transplant. Recovery was defined as eGFR >20 ml/min and no dialysis. LOS was defined as hospital days until first discharge. Enrollment goal was set at 40. Preliminary results: presented here with 8 patients enrolled: 5 Treatment, 3 Control. All patients required dialysis pre-enrollment. All control patients received cyclosporine and MPA during first hospital stay. Average enrollment post-op day 5.5 (SD 1.09). Average time to recovery T= 8.6 (SD 5.6), C= 27 (SD 9.2). Average dialysis post enrollment T= 0.4 (SD 0.8), C= 10 (SD 3.5). Average LOS T=11.2 (SD 1.3). C= 13.7 (SD 3.2). Mean 30-day creat T= 1.3 (SD 0.6), C= 2.4 (SD 0.7). Rejections<30 days: T=1, C=1. Conclusions: While preliminary and designed as a pilot study, use of Costimulatory blockade with Belatacept in combination with MPA/steroid and avoidance of CNI appears to allow more rapid recovery from DGF, shorter LOS and less dialysis with no increased rejection risk above attributed to DGF itself. Though underpowered so far due to small numbers, trends shown here are promising.

CITATION INFORMATION: Von Visger J, Diez A, Nori U, Pesavento T, Pelletier R, Rajab A, El Hinnawi A, Winters H. Costimulatory Blockade in Delayed Graft Function. Am J Transplant. 2017;17 (suppl 3).

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