Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Collaborator: Veloxis Pharmaceuticals
• Treatments: Antilymphocyte Serum; Antimetabolites; Azathioprine; Basiliximab; Methylprednisolone; Mycophenolic Acid; Prednisone; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

• 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%

Exclusion Criteria:

• Repeat kidney transplant recipients

• cPRA >20%

• rATG (rabbit anti-thymocyte globulin) induction >6mg/kg at time of induction

• Crossmatches deemed positive by accepting physician

• Presence of pre-formed anti-HLA (anti-Human Leukocyte Antigen) DSA (Donor-Specific Antibody) as defined by MFI (mean fluorescence intensity) approaching 3000 using flow cytometry/Luminex-based, specific anti-HLA antibody testing.

• Receipt of desensitization protocols

• History of skin cancer

• Recipient of multi-organ or dual kidney transplants

• For any condition, in which the investigator's opinion makes the subject unsuitable for study