Envarsus in Delayed Graft Function (E-DGF)

Phase 4

Completed

Brief Summary: Envarsus XR is an extended release tacrolimus designed to deliver tacrolimus more consistently, thus avoiding large fluctuations of tacrolimus trough levels with Envarsus XR compared to immediate release tacrolimus. It is expected that patients with DGF on Envarsus XR will have more stable tacrolimus levels and facilitate early recover from DGF compared to immediate release tacrolimus.

Detailed Description: This is a single center randomized phase IV trial of comparing extended release Envarsus XR (study drug) once a day vs immediate release tacrolimus twice a day in a new kidney transplant recipients with delayed graft function (DGF). The primary study endpoint is the interval between first dialysis and last dialysis after kidney transplant (duration of DGF). The second end point is the number of tacrolimus or Envarsus XR dose adjustments required during the period of DGF.

Recruitment & Eligibility

Inclusion Criteria

Willing and able to provide written informed consent
Willing to comply with all study procedures and be available for the duration of the study
Male or female, at least 18 years of age
Documented diagnosis of DGF or need for dialysis or had dialysis within the first week of kidney transplant
Current treatment with tacrolimus based regimen or planned to start tacrolimus based immunosuppressive regimen
Females of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization, for the duration of study participation, and for 7 days following completion of therapy.
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  - Has not undergone a hysterectomy or bilateral oophorectomy; or
  - Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria

History of hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes
Current use of non-tacrolimus based immunosuppressive regimen or no plan to start tacrolimus based regimen
Women who are or plan to become pregnant or breast-feeding during the study period
Not suitable for study participation due to other reasons at the discretion of the investigator
Major post-surgical complications requiring allograft nephrectomy
Multi-organ transplant recipients
Non kidney transplant recipients

Arm && Interventions

Group	Intervention	Description
Experimental	Envarsus XR	Envarsus XR
Standard of Care	Tacrolimus	Standard of Care Tacrolimus

Primary Outcome Measures

Name	Time	Method
Number of Days Needed to Recover From Delayed Graft Function (DGF)	up to 3 months post transplant	The primary endpoint of the study will be the length of time between first dialysis and last dialysis after kidney transplant (duration of DGF).

Secondary Outcome Measures

Name	Time	Method
Number of Tacrolimus or Envarsus XR Dose Adjustments Required During the Period of DGF	up to 3 months post transplant	The secondary endpoint will be number of tacrolimus or Envarsus XR dose adjustments required during the period of DGF.