SIMPLE Study: A Prospective and Randomized Trial of a Simplified Immunosuppressive Protocol Utilizing Low Dose EnvarsusXR
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The purpose of this study is to determine if the combination of once-daily tacrolimus extended-release (EnvarsusXR) and Azathioprine is non inferior with respect to the composite outcome of acute rejection, graft and patient survival as compared to a combination of twice-daily immediate release tacrolimus and mycophenolate mofetil/mycophenolic acid.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• De- Novo Kidney transplant patients between 18 and 85 years old
• Cold ischemia time (CIT) \< 24 hours for 3-6 HLA mismatches between donor and recipient and CIT \>24 hours for HLA mismatch of less than 3 between donor and recipient
• Most recent pre-transplant cPRA (calculated panel reactive antibody) ≤ 20%
Locations
United States
California
University of Southern California
RECRUITING
Los Angeles
Contact Information
Primary
Melissa Ramos, BSN
Melissa.Ramos@med.usc.edu
323-442-7983
Time Frame
Start Date: 2021-11-23
Estimated Completion Date: 2025-02
Participants
Target number of participants: 80
Treatments
Active_comparator: Twice-daily Regimen
Twice-daily regimen of immediate release tacrolimus, mycophenolate mofetil (MMF)/mycophenolic acid (MPA) plus daily methylprednisolone or prednisone.
Active_comparator: Once-daily Regimen
Once-daily regimen of Envarsus, azathioprine plus methylprednisolone or prednisone.
Related Therapeutic Areas
Sponsors
Leads: University of Southern California
Collaborators: Veloxis Pharmaceuticals