Status:
COMPLETED
Envarsus in Delayed Graft Function (E-DGF)
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Delayed Graft Function
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 rele...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03864926
Start Date
March 18 2019
End Date
July 22 2022
Last Update
July 20 2023
Active Locations (1)
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1
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792