RECRUITING

Renal Tubular Injury and Transplant Outcomes in Cardiac Recipients Converting From IR Tacrolimus to XR Tacrolimus

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 higher peak levels compared to non-expressors. Tacrolimus XR (Envarsus) is a once daily formulation with delayed absorption and lower peak levels while maintaining similar trough levels as seen with IR tacrolimus. A randomized trial of conversion from IR tacrolimus to tacrolimus XR in kidney transplant recipients have shown similar efficacy and adverse events between the two groups but no improvement in estimated GFR. However, urinary biomarkers of acute kidney injury associated with changes in tacrolimus dosing may be more sensitive then serum creatinine. The objective of this study is to assess renal tubular injury in heart transplant recipients who are converted from immediate release to tacrolimus XR. The hypothesis is that the delayed absorption and lower peak levels of tacrolimus XR will lead to less tubular injury and improved renal function without increased risk to the heart allograft.

Official Title

Assessment of Renal Tubular Injury and Transplant Outcomes in Cardiac Recipients Converting From Immediate Release Tacrolimus to Extended Release Tacrolimus.

Quick Facts

Study Start:2021-08-16
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04917718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Stable, heart-only transplant recipient within 10 years of transplantation
  2. * 18 -80 years old
  3. * Currently taking IR Tacrolimus
  4. * Baseline eGFR\> 30mL/min/1.73m2
  1. * Multiple organ transplant recipients
  2. * Less than 18 years old
  3. * Greater than 80 years old
  4. * Heart-only transplants recipients with active malignancy, rejection, or greater than 10 years from transplantation

Contacts and Locations

Study Contact

Sanjeev Akkina, MD
CONTACT
708-327-4897
sanjeev.akkina@lumc.edu

Principal Investigator

Sanjeev Akkina, MD
PRINCIPAL_INVESTIGATOR
Loyola University

Study Locations (Sites)

Loyola University Medical Center
Maywood, Illinois, 60153
United States

Collaborators and Investigators

Sponsor: Loyola University

  • Sanjeev Akkina, MD, PRINCIPAL_INVESTIGATOR, Loyola University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-16
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2021-08-16
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Immediate Release Tacrolimus
  • Extended Release Tacrolimus
  • IR Tacrolimus
  • XR Tacrolimus
  • Renal Tubular Injury
  • Heart Transplant Recipient
  • Chronic Kidney Disease

Additional Relevant MeSH Terms

  • Chronic Kidney Diseases
  • Heart Transplant