Clinical trial NCT03864926: Envarsus in Delayed Graft Function (E-DGF)
Official title: Envarsus in Delayed Graft Function: A Phase IV, Randomized, Single Center Study Among Kidney Transplant Recipients With Delayed Graft Function (DGF) to Study the Effect of Envarsus XR in the DGF Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Delayed Graft Function
Keywords: Kidney Transplant
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Veloxis Pharmaceuticals
First posted: 2019-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Days Needed to Recover From Delayed Graft Function (DGF)
timeFrame: up to 3 months post transplant
Secondary outcomes:
measure: Number of Tacrolimus or Envarsus XR Dose Adjustments Required During the Period of DGF
timeFrame: up to 3 months post transplant
Other outcomes:
measure: Number of Participants Experiencing Related Adverse Events
timeFrame: up to 3 months post transplant
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin School of Medicine and Public Health, Madison
name: Sandesh Parajuli, MBBS
role: PRINCIPAL_INVESTIGATOR
References: