RECRUITING

Prospective Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients

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 investigator-initiated post-marketing study will evaluate the role of Hispanic ethnicity on drug dosing of Envarsus in first-time stable renal transplant recipients. Tacrolimus trough drug levels will be studied as a primary endpoint at 24 hours after drug dosing and at steady state (e.g., trough level at 3 months post conversion) and secondary compliance assessments will be done by pill counts at clinic visits. Secondary outcomes will be the safety of once a day dosing as well as assessment of graft rejection and graft failure. In addition, concentration/dose ratios will be analyzed. The results of this study will provide important information about dosing of once a day tacrolimus (Envarsus) in Hispanic kidney transplant patients, which represents the largest growing group of patients with End-Stage Renal Disease

Official Title

Prospective Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients

Quick Facts

Study Start:2018-07-11
Study Completion:2023-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03438773

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or Female 18 years of age or older.
  2. * The subject is a first time stable renal transplant patients, who have received their transplant at least 3 months before study entry.
  3. * The subject is willing to commit to the study design.
  4. * The subject is considered to have stable allograft function defined as no documented rejection episodes within one month of screening.
  5. * The subject is not currently receiving treatment with other experimental therapies directed at their transplant.
  1. * The subject has undergone a prior organ or bone marrow transplant.
  2. * The subject has taken any interacting/contraindicated drug determined by the Investigator within 30 days of administration of the protocol.
  3. * Any study drug allergies and if there are high serum donor specific antibody levels (DSA) or a high panel reactive antibody level (PRA).
  4. * Documented treatment of rejection within 30 days of onset of the screening visit.

Contacts and Locations

Study Contact

Michael C Gastauer
CONTACT
858-810-8155
mgastauer@balboaunited.org
Eva Gripp, LVN
CONTACT
858-637-4600
EGripp@balboaunited.org

Principal Investigator

Arman Faravardeh, MD
PRINCIPAL_INVESTIGATOR
California Institute of Renal Research

Study Locations (Sites)

California Institute of Renal Research
San Diego, California, 92123
United States

Collaborators and Investigators

Sponsor: California Institute of Renal Research

  • Arman Faravardeh, MD, PRINCIPAL_INVESTIGATOR, California Institute of Renal Research

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 Date2018-07-11
Study Completion Date2023-12

Study Record Updates

Study Start Date2018-07-11
Study Completion Date2023-12

Terms related to this study

Keywords Provided by Researchers

  • Hispanic
  • First time kidney recipients

Additional Relevant MeSH Terms

  • Kidney Transplant; Complications
  • Kidney Transplant Failure and Rejection