Envarsus in Delayed Graft Function (E-DGF)
Condition: Delayed Graft Function
MeSH terms: Delayed Graft Function
Intervention: Envarsus XR; Tacrolimus
Intervention description: Envarsus XR is FDA approved for the prophylaxis of organ rejection in kidney transplant recipients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants. Envarsus XR, is designed to deliver tacrolimus more smoothly over the whole day.
Envarsus XR, a calcineurin-inhibitor immunosuppressant, is available for oral administration as extended-release tablets containing the equivalent of 0.75 mg, 1 mg, or 4 mg of anhydrous tacrolimus USP. Inactive ingredients include hypromellose USP, lactose monohydrate NF, polyethylene glycol NF, poloxamer NF, magnesium stearate NF, tartaric acid NF, butylated hydroxytoluene NF, and dimethicone NF. Tacrolimus is the active ingredient in ENVARSUS XR.; Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients.
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney Transplant

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing and able to provide written informed consent

          2. Willing to comply with all study procedures and be available for the duration of the
             study

          3. Male or female, at least 18 years of age

          4. Documented diagnosis of DGF or need for dialysis or had dialysis within the first week
             of kidney transplant

          5. Current treatment with tacrolimus based regimen or planned to start tacrolimus based
             immunosuppressive regimen

          6. 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:

          1. History of hypersensitivity or allergy to any of the study drugs or drugs of similar
             chemical classes

          2. Current use of non-tacrolimus based immunosuppressive regimen or no plan to start
             tacrolimus based regimen

          3. Women who are or plan to become pregnant or breast-feeding during the study period

          4. Not suitable for study participation due to other reasons at the discretion of the
             investigator

          5. Major post-surgical complications requiring allograft nephrectomy

          6. Multi-organ transplant recipients

          7. Non kidney transplant recipients