Status:
COMPLETED
Evaluation Dose Adjustments in Kidney Transplant Patients on Immediate Release and Extended Release Tacrolimus
Lead Sponsor:
Sentara Norfolk General Hospital
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Transplant;Failure,Kidney
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Evaluation Dose Adjustments in Kidney Transplant Patients on Immediate Release and Extended Release Tacrolimus
Detailed Description
1. Background and Rationale- The novel once-daily extended-release tacrolimus (ERT) has been shown to be non-inferior to twice-daily tacrolimus (TDT) during induction immunotherapy for kidney transpla...
Eligibility Criteria
Inclusion
- Age 18-70
- Receiving a kidney transplant at Sentara Norfolk General Hospital
- Able to give informed consent
Exclusion
- Multi-organ transplant
- Previous functioning transplant
- Prior surgery to the gastrointestinal tract that alters the normal anatomy with the exception of cholecystectomy
- Women of childbearing potential who cannot or are unwilling to maintain adequate contraception during the course of this study.
Key Trial Info
Start Date :
January 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03760263
Start Date
January 16 2020
End Date
November 1 2023
Last Update
February 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507