This is a one year, prospective, randomized, open-label trial examining once versus twice daily tacrolimus dosing regimen using two preparations, extended-release Tacrolimus (Envarsus XR) versus twice daily Tacrolimus (Prograf). It will examine kidney function between the two groups using estimated glomerular filtration rate (eGFR) and also examine one-year kidney outcomes, including graft loss and patient death. Patients will be followed for up to 1 year during the open-label study period.
Despite lower rates of acute rejection and short-term improvements in patient and graft survival, the rate of late allograft loss following kidney transplantation has remained unchanged. Achievement of therapeutic, minimally toxic, tacrolimus concentrations early (within 30 days), after transplantation, is known to be important since achieving it has been associated with a lowered risk of acute rejection. The investigators hypothesize that using extended release tacrolimus (Envarsus XR, Veloxis), will provide more stable, more effective, and less toxic levels of tacrolimus in renal allograft recipients. Therefore, the investigators propose to analyze the impact of the blood concentration normalized by the dose (C/D ratio) on kidney function after renal transplantation in experimental group that will be treated with Envarsus XR and the standard of care (SOC) group treated with twice a day tacrolimus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
Tacrolimus, extended-release, oral (Envarsus); 0.75 mg, 1 mg, 4 mg tablets will be administered once daily at initial weight-based dose of 0.12 mg/kg.
Tacrolimus immediate-release, oral; 0.5 mg, 1 mg, 5 mg capsules will be administered twice daily per clinical judgment of supervising physician
Columbia University Medical Center
New York, New York, United States
Mean C/D Ratio
Tacrolimus metabolism was determined for all dates of tacrolimus blood trough concentration collection after renal transplantation by dividing the tacrolimus blood trough concentration (C) by the corresponding total daily tacrolimus dose (D). C/D ratio (ng/mL\*1/mg) = blood tacrolimus trough level (ng/mL)/total daily tacrolimus dose (mg).
Time frame: Every Month for up to 1 year
Mean Serum Creatinine Level
Serum creatinine levels were measured to assess kidney function following transplantation
Time frame: 12 months
Patient Survival Rate
Patient survival is any subject that is known to be alive at the study conclusion.
Time frame: 12 months
Graft Survival Rate
Graft survival is defined as any subject that does not fit the following definition of graft loss: subject death, re-transplantation, transplant nephrectomy, or return to dialysis for a period of ≥6 weeks by study end.
Time frame: 12 months
Number of Rejection Episodes
For study purposes, diagnoses of rejection require biopsy confirmation.
Time frame: 12 months
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