RECRUITING

Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile

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

This will be a single center, prospective, open-label, randomized, controlled trial comparing Envarsus XR® to twice-daily tacrolimus. The targeted population will be patients with end stage renal disease listed for primary solitary kidney transplant. Transplant Surgery is not part of the study.

Official Title

Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile

Quick Facts

Study Start:2019-03-28
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03321656

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 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Fluent in English able to understand and provide informed consent.
  2. * End stage renal disease listed for primary solitary kidney transplant.
  3. * Willing to participate in the study and comply with study requirements as evidenced by signed IRB-approved informed consent.
  4. * Female who are of childbearing potential will be asked to use 2 different medically acceptable methods of contraception for the duration of the study and at least 1 year post-infusion.
  1. * Previously undergone organ, tissue or cell transplant
  2. * Allergic to Tacrolimus or MMF (Cellcept)
  3. * Chronic use of blood thinners
  4. * Previous chronic use of glucocorticoids or other immunosuppression, or biologic immunomodulators (prescribed for the treatment of serious inflammatory disorders)
  5. * Significant or active infection
  6. * Diagnosed with HIV, Hepatitis B or C, Herpes simplex virus, Varicella-Zoster virus, Epstein-Barr virus
  7. * Have or have had cancer with in the past 3 years
  8. * Have taken part in another study that involved an investigational drug within the last 12 months.
  9. * Have a history of delayed or abnormal wound healing
  10. * Are pregnant or breastfeeding
  11. * Had a transfusion within the past 3 months
  12. * Have or plan to be receive a live vaccination (intranasal influenza measles, mumps, rubella, oral polio, yellow fever, varicella)
  13. * Are unable or unwilling to comply with study protocol or procedures.
  14. * Current use anticoagulation medication

Contacts and Locations

Study Contact

Deepa Valvi, DrPH
CONTACT
8592579443
deepa.valvi@uky.edu

Principal Investigator

Roberto Gedaly, MD
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

Deepa Valvi
Lexington, Kentucky, 40536
United States

Collaborators and Investigators

Sponsor: Roberto Gedaly

  • Roberto Gedaly, MD, PRINCIPAL_INVESTIGATOR, University of Kentucky

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 Date2019-03-28
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2019-03-28
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • End Stage Renal Disease