Kidney Week

Abstract: SA-PO511

Randomized Controlled Trial Assessing the Impact of Conversion to Everolimus with Ultra-Low Tacrolimus Exposure on Graft Outcomes in Kidney Transplant Recipients

Session Information

• Immunosuppression, Disease Recurrence, and Malignancy
  November 04, 2017 | Location: Hall H, Morial Convention Center
  Abstract Time: 10:00 AM - 10:00 AM

Category: Transplantation

• 1702 Transplantation: Clinical and Translational

Authors

• Taber, David J., Medical University of South Carolina, Charleston, South Carolina, United States

David J. Taber,

• Chokkalingam, Avudaiappan, Mayo Clinic, Rochester, Minnesota, United States

Avudaiappan Chokkalingam,

• Su, Zemin, Medical University of South Carolina, Charleston, South Carolina, United States

Zemin Su,

• Srinivas, Titte, Intermountain Medical Center, Murray, Utah, United States

Titte Srinivas,

Background

Despite low rate of acute rejection, the triple regimen of tacrolimus (FK), mycophenolate (MMF) and prednisone can increase the risk of late graft loss due to nephrotoxicity and opportunistic infections.

Methods

Single-center, randomized, controlled trial assessing the impact of a three month conversion to EVR with ultra-low FK exposure, compared to the regimen of full exposure FK with MMF (NCT 02096107). Adult, solitary kidney transplant recipients with a functioning graft at 3 months were eligible for inclusion. Goal trough levels in the intervention arm were 2-5 ng/mL for FK and 3-8 ng/mL for EVR, while FK was maintained at 5-12 ng/mL in the control arm.

Results

60 patients were randomized (30 in each arm). Groups were well matched at baseline (3 months post-transplant), except there were fewer females in the intervention arm. FK levels were significantly lower in the EVR arm (Figure 1). At 12-months post-transplant, acute rejection rates (7% FK/MMF vs. 3% FK/EVR, p=0.554, Table 1) and graft function (mean eGFR FK/MMF 56±15 vs FK/EVR 59±14 mL/min/1.73 m², p=0.465; Figure 2) were similar between arms. The EVR/ultra-low FK arm had significantly lower rates of CMV infection, severe BK infection and improved BK viral clearance kinetics (Figure 3). All safety measures, including immunosuppression discontinuation, hospitalizations, and graft and patient loss were similar between arms (Table 1).

Conclusion

An immunosuppression conversion regimen of EVR with ultra-low exposure FK provides equally sufficient immunosuppression prophylaxis efficacy as compared to standard exposure FK and MMF, with the potential advantage of significantly lower rates of opportunistic viral infections, including BK and CMV.

Funding

• Commercial Support – Novartis Pharmaceuticals