Status:
TERMINATED
Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Kidney Transplantation
Kidney Transplant Rejection
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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 reje...
Detailed Description
While short-term graft outcomes in kidney transplantation have improved, this requires adherence to a complex medication regimen. The current twice-daily immunosuppressive regimen, immediate release t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04773392
Start Date
November 23 2021
End Date
February 23 2024
Last Update
November 10 2025
Active Locations (1)
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1
University of Southern California
Los Angeles, California, United States, 90033