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Kidney Week

Abstract: FR-PO1177

The Potential for Improved Medication Adherence with a Complete Once Daily Immunosuppression Regimen in Kidney Transplant: Results of a Randomized Controlled Study

Session Information

Category: Transplantation

  • 1902 Transplantation: Clinical

Authors

  • Taber, David J., Medical University of South Carolina , Charleston, South Carolina, United States
  • Posadas, Maria Aurora C., Medical University of South Carolina , Charleston, South Carolina, United States
  • Rao, Vinaya, Medical University of South Carolina , Charleston, South Carolina, United States
  • Mcgillicuddy, John, Medical University of South Carolina , Charleston, South Carolina, United States
  • Rohan, Vinayak, Medical University of South Carolina , Charleston, South Carolina, United States
  • Nadig, Satish N., Medical University of South Carolina , Charleston, South Carolina, United States
  • Dubay, Derek, Medical University of South Carolina , Charleston, South Carolina, United States
  • Fleming, James, Medical University of South Carolina , Charleston, South Carolina, United States
Background

Medication non-adherence is common after transplant and a major contributor to rejection and graft loss. The objective of this study was to obtain preliminary safety, tolerability and efficacy data of a complete once daily immunosuppression regimen of LCP-Tac (Envarsus XR), everolimus and pred, compared to LCP-Tac, mycophenolate BID and pred.

Methods

This was a randomized, controlled pilot study with the primary aim of assessing self-reported medication adherence and comparing this between a once and twice daily immunosuppressant regimen. At 3±2 months post-transplant, patients were randomized to receive LCP-Tac and everolimus once daily or LCP-Tacand mycophenolate BID (control arm) for 6-months.

Results

354 were screened, 80 met eligibility, and 40 were randomized. The mean age was 51±14 years, 33% were female, 45% African-American, and 55% had a cPRA >20%. Baseline characteristics were similar between study arms. Tac exposure was lower in the intervention arm (left side of Figure). Self-reported high medication adherence was higher at baseline in the control group (80% vs. 45%, p=0.049), which equilibrated at study end (59% vs. 47%, p=0.525; right side of Figure). Medication side effect burden tended to be less severe in the intervention group, with both regimens being well tolerated. For QOL, role limitations improved in the entire study group similarly across arms while social functioning trended towards improving to a greater degree in the intervention arm (net change: +8.8 intervention arm, -4.1 control arm; p=0.0898). There were no acute rejections, graft loss or death in either arm during the study.

Conclusion

These results provide preliminary evidence of the safety, efficacy, tolerability and potential benefit of sustaining high medication adherence with a novel once daily immunosuppression regimen.

Funding

  • Commercial Support