Status:
UNKNOWN
Prospective Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients
Lead Sponsor:
California Institute of Renal Research
Collaborating Sponsors:
Balboa Institute of Transplantation
University of California, San Diego
Conditions:
Kidney Transplant; Complications
Kidney Transplant Failure and Rejection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This investigator-initiated post-marketing study will evaluate the role of Hispanic ethnicity on drug dosing of Envarsus in first-time stable renal transplant recipients. Tacrolimus trough drug levels...
Detailed Description
Adequate drug dosing is essential to prevent allograft rejection and subsequent allograft loss. Many studies have shown that serum levels of immunosuppressant medications can be strongly influenced by...
Eligibility Criteria
Inclusion
- Male or Female 18 years of age or older.
- The subject is a first time stable renal transplant patients, who have received their transplant at least 3 months before study entry.
- The subject is willing to commit to the study design.
- The subject is considered to have stable allograft function defined as no documented rejection episodes within one month of screening.
- The subject is not currently receiving treatment with other experimental therapies directed at their transplant.
Exclusion
- The subject has undergone a prior organ or bone marrow transplant.
- The subject has taken any interacting/contraindicated drug determined by the Investigator within 30 days of administration of the protocol.
- Any study drug allergies and if there are high serum donor specific antibody levels (DSA) or a high panel reactive antibody level (PRA).
- Documented treatment of rejection within 30 days of onset of the screening visit.
Key Trial Info
Start Date :
July 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03438773
Start Date
July 11 2018
End Date
December 1 2023
Last Update
February 9 2023
Active Locations (1)
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1
California Institute of Renal Research
San Diego, California, United States, 92123