Envarsus in Delayed Graft Function (E-DGF)

PHASE4CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 18, 2019

Primary Completion Date

July 22, 2022

Study Completion Date

July 22, 2022

Conditions
Delayed Graft Function
Interventions
DRUG

Envarsus XR

"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."

DRUG

Tacrolimus

Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients.

Trial Locations (1)

53792

University of Wisconsin Hospital and Clinics, Madison

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Veloxis Pharmaceuticals

INDUSTRY

lead

University of Wisconsin, Madison

OTHER