In kidney transplant patients switched from immediate-release tacrolimus
ENVARSUS XR efficacy is proven comparable to Prograf®Efficacy of ENVARSUS XR: Clinical study, patients switched from Prograf Clinical trial patient demographics Adverse events associated with ENVARSUS XR: Clinical study, patients switched from Prograf
With a primary efficacy endpoint of treatment failure at 1 year, treatment difference for ENVARSUS XR vs Prograf was 0% (95% CI [–4.2%, 4.2%]), well within the 9% prespecified non-inferiority margin.2†
No acute rejection episodes in first 30 days post conversion3
Renal function was maintained
Mean eGFR Over 1 Year, ENVARSUS XR vs Prograf2*
20% lower tacrolimus dose
Change From Baseline, Mean Tacrolimus Daily Dose by Study Visit2*
ENVARSUS XR dose was significantly reduced from baseline at each study visit (P<0.0001).2
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Multicenter, multi-national trial
Conversion as early as 3 months post-transplant
|Median Age, years||50||50|
|Male, n (%)||116 (72%)||101 (62%)|
|Race, n (%)|
|Caucasian||120 (74%)||116 (72%)|
|African-American||35 (22%)||34 (21%)|
|  Asian||3 (2%)||3 (2%)|
|Other||4 (2.5%)||9 (5.5%)|
P=not significant for all values
|In Kidney Transplant Patients: Most common (≥5%) adverse reactions through 1 year of post conversion1‡ (P=not significant for all measures)|
|Blood creatinine increased||12%||9%|
|Urinary tract infection||9%||14%|
|Upper respiratory tract infection||7%||9%|
There were no significant differences between the ENVARSUS XR and Prograf groups in predefined potentially clinically significant laboratory measures incidence of new onset diabetes mellitus, opportunistic infection, or malignancies.1Return to top ↟
- Study Design: The efficacy and safety of ENVARSUS XR was evaluated in an internationally conducted multicenter (n=33 US, n=14 Europe) open-label study of stable adult kidney transplant recipients 3 months to 5 years post-transplant (N=326) converted from Prograf to ENVARSUS XR. According to standard of care, concomitant therapy with mycophenolate mofetil (MMF), azathioprine (AZA), and corticosteroids was permitted but not required. Patients were converted to ENVARSUS XR at a reduced dose or continued Prograf at the same dose.2
- Treatment failure at 12 months was a composite endpoint of death, graft failure, BPAR, and patients lost to follow-up.
- Study was not designed to support comparative claims of ENVARSUS XR compared to tacrolimus immediate-release for the adverse reactions reported in this table.
BPAR, biopsy-proven acute rejection; CI, confidence interval; eGFR, estimated glomerular filtration rate
- ENVARSUS XR [prescribing information]. Edison, NJ: Veloxis Pharmaceuticals; 2015.
- Bunnapradist S, Ciechanowski K, West-Thielke P, et al. Conversion from twice-daily tacrolimus to once-daily extended release tacrolimus (LCPT): the phase III randomized MELT trial. Am J Transplant. 2013;13:760–769.
- Data on file. Veloxis Pharmaceuticals, Inc.