Abstract: FR-PO1186
Safety and Efficacy of LCP-Tacrolimus (LCPT) in Hispanic De Novo Kidney Transplant Recipients (KTR)
Session Information
- Transplantation: Clinical - Immunosuppression, Adherence, Outcomes
November 08, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Transplantation
- 1902 Transplantation: Clinical
Authors
- Villicana, Rafael, Loma Linda University, Loma Linda, California, United States
- Guerra, Giselle, University of Miami/Miller School of Medicine, Miami, Florida, United States
- Moten, Misbah A., Veloxis Pharmaceuticals, Cary, North Carolina, United States
- Patel, Samir J., 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
- Bunnapradist, Suphamai, University of California Los Angeles, Los Angeles, California, United States
Background
Safety and efficacy of once daily, LCPT have been established among various subgroups of KTR, however outcomes in Hispanic patients have yet to be analyzed. The purpose of this analysis was to investigate treatment failure and safety outcomes in Hispanic de novo KTR on LCPT or twice daily, immediate-release tacrolimus (IR-TAC).
Methods
A post hoc, subgroup analysis of patients identifying as Hispanic/Latino from a phase III randomized controlled trial was conducted. Patients were dosed at 0.17 mg/kg/day LCPT and 0.1 mg/kg/day IR-TAC on day 1, with target tacrolimus trough concentrations of 6-11ng/mL for the first month, then 4-11ng/mL. Treatment failure was defined as a composite of biopsy-proven rejection (BPAR), graft loss, death, and loss-to-follow up. Concomitant immunosuppressants included basiliximab induction, mycophenolate, and steroids.
Results
Seventy-four LCPT and 79 IR-TAC patients were included in the analysis. Demographics were similar between the two groups. Overall, fewer treatment failures occurred in Hispanic LCPT recipients compared to those on IR-TAC at 12 months (12.2% vs. 25.3%, p=0.04). BPAR largely accounted for the difference in efficacy (Table 1). Mean tacrolimus trough levels were higher with LCPT during the first 2 weeks post-transplant and similar thereafter. Renal function remained stable from 1 month to 12 months for LCPT patients, however the incidence of NODAT at 12 months in at-risk patients was 18.8% in LCPT patients and 3.8% in IR-tac patients (p=0.057). Remaining adverse events and opportunistic infections were similar between groups.
Conclusion
Hispanic de novo KTR on LCPT experienced fewer treatment failures at 12 months, however a trend towards increased NODAT was noted. These findings may support the approved, lower recommended initial dose (0.14 mg/kg) in this population.
Efficacy and Renal Function
| Outcome | LCPT (n=74) | IR-TAC (79) | p-value |
| Composite 12 Month Treatment Failure, n(%) | 9 (12.16%) | 20 (25.32%) | 0.04 |
| BPAR, n(%) | 7 (9.46%) | 16 (20.25%) | 0.07 |
| Death, n(%) | 1 (1.35%) | 3 (3.80%) | 0.62 |
| Graft Failure, n(%) | 2 (2.70%) | 4 (5.06%) | 0.68 |
| Lost to Follow Up, n(%) | 0 | 2 (2.53%) | 0.50 |
| 1 Month GFR, mean(SD) | 61.8 (23.03) (n=69) | 63.0 (23.07) (n=72) | 0.75 |
| 6 Months GFR, mean(SD) | 60.2 (19.89) (n=68) | 65.9 (20.32) (n=68) | 0.17 |
| 12 Months GFR, mean(SD) | 60.8 (18.38) (n=68) | 68.6 (19.38) (n=68) | 0.03 |
| General linear model fixed effect p-values for renal function over 12 months: Treatment, p=0.18; Day, p=0.20; Treatment*Day, p=0.06 | |||
Funding
- Commercial Support – Veloxis Pharmaceuticals