Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR

PHASE4RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 23, 2021

Primary Completion Date

February 28, 2025

Study Completion Date

February 28, 2025

Conditions
Kidney TransplantationKidney Transplant Rejection
Interventions
DRUG

Twice-daily Tacrolimus

Within 48 hours of transplantation, immediate release tacrolimus (IRT) (0.1 mg/kg /day) will be administered twice a day.

DRUG

Once-daily envarsus XR

Within 48 hours of transplantation, Envarsus XR (0.13mg/kg/day) will be administered once a day.

DRUG

Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG)

Induction immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG) per protocol. The dose of Basiliximab will be a standard of two 20 mg doses and total rATG will not exceed 6 mg/kg.

DRUG

Methylprednisolone, prednisone

Methylprednisolone intraoperatively (500mg) and immediately post transplantation (200mg on post operative day (POD) #1, 150mg on POD#2, 100mg on POD#3) then oral prednisone (50mg on POD #4, 20mg on POD #5). Oral prednisone will be tapered down to a minimal dose of 5mg within 6 weeks post transplantation.

DRUG

Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA)

Mycophenolate mofetil (MMF) (up to 1000mg) or Mycophenolic acid (MPA) (up to 720mg) will be administered twice a day.

DRUG

Azathioprine

Azathioprine (1-3 mg/kg) will be administered once a day.

Trial Locations (1)

90033

RECRUITING

University of Southern California, Los Angeles

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Veloxis Pharmaceuticals

INDUSTRY

lead

University of Southern California

OTHER