Review the publications
Veloxis supported a robust development program for ENVARSUS XR, including 27 trials and more than 1657 patients.
Read further to see a partial list of the ENVARSUS XR studies and a brief overview of the results. To leave the ENVARSUS XR website and review the full studies, click on the associated links.
Novel Once-Daily Extended-Release Tacrolimus (LCPT) Versus Twice-Daily Tacrolimus in De Novo Kidney Transplants: One-Year Results of Phase III, Double-Blind, Randomized Trial
This study validated the efficacy and safety of ENVARSUS XR versus Prograf® in de novo kidney transplant patients (N=543) over 12 months. Results showed noninferiority with lower doses compared with Prograf.
Budde K, Bunnapradist S, Grinyo JM, Ciechanowski K, Denny JE, Silva HT, Rostaing L, on behalf of the Envarsus study group. American Journal of Transplantation. 2014;14(12):2796-2806.Read the paper
Novel Once-Daily Extended-Release Tacrolimus Versus Twice-Daily Tacrolimus in De Novo Kidney Transplant Recipients: Two-Year Results of Phase 3, Double-Blind, Randomized Trial
Final 24-month analysis of a 2-armed, parallel-group, randomized, double-blind, double-dummy, multicenter, phase 3 trial.
Rostaing L, Bunnapradist S, Grinyo JM, Ciechanowski K, Denny JE, Silva HT, Budde K, on behalf of the Envarsus Study Group. American Journal of Kidney Disease. 2016;67(4):648-659.Read the paper
Conversion From Twice-Daily Tacrolimus to Once-Daily Extended Release Tacrolimus (LCPT): The Phase III Randomized MELT Trial
This study confirmed the efficacy and safety of ENVARSUS XR in kidney transplant patients (N=326) converted from twice-daily immediate-release tacrolimus. Patients required lower doses of ENVARUS XR to achieve target trough levels.
Bunnapradist S, Ciechanowski K, West-Thielke P, Mulgaonkar S, Rostaing L, Vasudev B, Budde K, on behalf of the MELT investigators. American Journal of Transplantation. 2013;13:760–769.Read the paper
Conversion From Twice-Daily Tacrolimus Capsules to Once-Daily Extended-Release Tacrolimus (LCPT): A Phase 2 Trial of Stable Renal Transplant Recipients
Stable kidney transplant patients can be safely converted from Prograf twice daily to ENVARSUS XR. The greater bioavailability of ENVARSUS XR allows for once-daily dosing and similar (AUC) exposure at a lower dose than Prograf with significantly lower peak-trough fluctuations. Please note, this study was not designed or powered to support establishing differences in safety or efficacy.
Gaber A, Alloway RR, Bodziak K, Kaplan B, and Bunnapradist S. Transplantation. 2013; 96:191–197.Read the paper
A Steady-State Head-to-Head Pharmacokinetic Comparison of All FK-506 (Tacrolimus) Formulations (ASTCOFF): An Open-Label, Prospective, Randomized, Two-Arm, Three-Period Crossover Study
This robust study was the first to examine the pharmacokinetic profiles of the 3 oral formulations of tacrolimus available in the US, confirming that the formulations have significantly different PK profiles. Please note, this study was not designed or powered to support establishing differences in safety or efficacy.
Tremblay S, Nigro V, Weinberg J, Woodle ES, Alloway RR. American Journal of Transplantation. 2017;17:432–442.Read the paper
Results of ASERTAA, a Randomized Prospective Crossover Pharmacogenetic Study of Immediate Release Tacrolimus versus Extended Release Tacrolimus in African American Kidney Transplant Recipients
This study compared the pharmacokinetics of ENVARSUS XR and IR-Tacrolimus in African-American patients. In the study, ENVARSUS XR demonstrated a consistent PK profile across genotypes. Please note, this study was not designed or powered to support establishing differences in safety or efficacy.
Trofe-Clark J, Brennan DC, West-Thielke P, Milone MC, Lim MA, Neubauer R, Nigro V, Bloom RD. American Journal of Kidney Disease. 2018: 71(3): 315 – 326Read the paper
Further research, reviews, and information
Pharmacokinetics of Tacrolimus: Achieving Adequate Exposure for Effective Immunosuppression
This white paper explores some of the literature addressing the unique pharmacokinetics of tacrolimus and the challenges that some patients face in achieving proper exposure. These considerations may be relevant when deciding how to consider pharmacokinetics in prescribing decisions for particular patients.Read the white paper Learn more about why ENVARSUS XR is different Explore programs for cost savings on ENVARSUS XR