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Kidney Week

Abstract: FR-PO1188

Safety and Efficacy of Conversion from Immediate-Release Tacrolimus (IR-TAC) to LCP-Tacrolimus (LCPT) in Hispanic Kidney Transplant Patients (KTR)

Session Information

Category: Transplantation

  • 1902 Transplantation: Clinical

Authors

  • Bunnapradist, Suphamai, University of California Los Angeles, Los Angeles, California, United States
  • Guerra, Giselle, University of Miami/Miller School of Medicine, Miami, Florida, United States
  • Patel, Samir J., Veloxis Pharmaceuticals, Cary, North Carolina, United States
  • Moten, Misbah A., Veloxis Pharmaceuticals, Cary, North Carolina, United States
  • Stevens, Daniel R., Veloxis Pharmaceuticals, Cary, North Carolina, United States
  • Meier-Kriesche, Ulf, Veloxis Pharmaceuticals, Cary, North Carolina, United States
  • Villicana, Rafael, Loma Linda University, Loma Linda, California, United States
Background

A large phase III study demonstrated safety and efficacy of once daily, LCPT in stable KTR converted from twice daily IR-TAC. Hispanic patients comprise a substantial proportion of KTR, however analyses within this cohort had yet to be conducted. The purpose of this subgroup analysis was to investigate treatment failure and safety outcomes of Hispanic KTR converted from IR-TAC to LCPT.

Methods

A post hoc, subgroup analysis from a phase III randomized controlled trial was conducted. Hispanic/Latino patients at least 3 months post-transplant on a stable IR-TAC dose were converted using a multiplier of 0.85 for non-Black recipients and 0.7 for Black recipients to maintain target tacrolimus trough concentrations of 4-15 ng/mL. Treatment failure was defined as a composite of for cause biopsy-proven acute rejection (BPAR), graft loss, death, and loss-to-follow up.

Results

55 patients were included in this analysis. LCPT and IR-TAC groups were similar with respect to age, gender, donor type, and sensitization. Overall, treatment failure was low for both LCPT and IR-TAC groups at 12 months post-conversion (3.85% vs. 3.45%, p=1.00) (Table 1). Tacrolimus trough levels remained similar in between groups throughout the study renal function was stable at 12 months post-conversion.

Adverse events related to study drug occurred in 27% of LCPT patients and 14% of IR-TAC patients (p=0.32), with no significant differences seen in any specific AE. Rates of new-onset diabetes and opportunistic infections were similar for both groups.

Conclusion

This analysis demonstrates safe and effective conversion from IR-TAC to LCPT in a subgroup of Hispanic KTR.

Table 1. Efficacy and Renal Function
OutcomeLCPT (n=26)IR-TAC (n=29)p-value
Composite 12 Month Treatment Failure, n (%)1 (3.85%)1 (3.45%)1.00
BPAR, n (%)1 (3.85%)00.47
Death, n(%)00n/a
Graft Failure, n(%)00n/a
Lost to Follow Up, n(%)01 (3.45%)1.00
Baseline GFR, mean (SD)66.5 (15.3) (n=26)70.5 (20.7) (n=29)0.39
1 Month GFR, mean(SD)67.4 (15.3) (n=22)70.2 (17.2) (n=25)0.18
6 Months GFR, mean(SD)65.0 (14.1) (n=18)74.2 (23.1) (n=24)0.05
12 Months GFR, mean(SD)71.5 (14.6) (n=18)74.0 (21.0) (n=24)0.36
General linear model fixed effect p-values for renal function over 12 months: Treatment, p=0.14; Day, p=0.80; Treatment*Day, p=0.11

Funding

  • Commercial Support