Status:
UNKNOWN
Renal Tubular Injury and Transplant Outcomes in Cardiac Recipients Converting From IR Tacrolimus to XR Tacrolimus
Lead Sponsor:
Loyola University
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Chronic Kidney Diseases
Heart Transplant
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Immediate release (IR) tacrolimus peaks in the first two hours after administration. These peak levels are influenced by CYP3A5 expression with expressors requiring higher total daily doses with highe...
Detailed Description
The primary outcome is change in urinary NGAL expression with conversion from IR tacrolimus to tacrolimus XR. In aim 1, changes in urinary biomarkers of tubular injury at 4 weeks after conversion to t...
Eligibility Criteria
Inclusion
- Stable, heart-only transplant recipient within 10 years of transplantation
- 18 -80 years old
- Currently taking IR Tacrolimus
- Baseline eGFR\> 30mL/min/1.73m2
Exclusion
- Multiple organ transplant recipients
- Less than 18 years old
- Greater than 80 years old
- Heart-only transplants recipients with active malignancy, rejection, or greater than 10 years from transplantation
Key Trial Info
Start Date :
August 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04917718
Start Date
August 16 2021
End Date
December 31 2024
Last Update
April 13 2022
Active Locations (1)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153