XR Tacrolimus for Heart Transplant Recipients
Trial Summary
What is the purpose of this trial?
This trial is testing Tacrolimus XR, a slow-release medication, in heart transplant recipients. The goal is to see if it reduces kidney damage by maintaining steady drug levels and avoiding high peaks. Researchers hope this will improve kidney function without harming the transplanted heart. Tacrolimus (FK 506) is a novel immunosuppressive agent that has been in clinical use for solid organ transplantation since 1989.
Research Team
Sanjeev Akkina, MD
Principal Investigator
Loyola University
Eligibility Criteria
This trial is for heart transplant recipients aged 18-80, within 10 years post-transplant, currently on IR Tacrolimus with stable function and a baseline kidney filtration rate (eGFR) over 30. It excludes those under 18 or over 80, with active cancer, recent rejection episodes, multiple organ transplants or more than a decade since their heart transplant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are converted from immediate release tacrolimus to extended release tacrolimus and monitored for changes in urinary biomarkers of tubular injury
Follow-up
Participants are monitored for changes in cardiac function, blood pressure, serum glucose, and cholesterol levels
Treatment Details
Interventions
- Tacrolimus
Tacrolimus is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:
- Prevention of organ rejection in liver, kidney, and heart transplant patients
- Prevention of organ rejection in liver, kidney, and heart transplant patients
- Prevention of organ rejection in liver, kidney, and heart transplant patients
- Prevention of organ rejection in liver, kidney, and heart transplant patients
- Prevention of organ rejection in liver, kidney, and heart transplant patients
Find a Clinic Near You
Who Is Running the Clinical Trial?
Loyola University
Lead Sponsor
Veloxis Pharmaceuticals
Industry Sponsor