RECRUITING

Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR

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

The purpose of this study is to determine if the combination of once-daily tacrolimus extended-release (EnvarsusXR) and Azathioprine is non inferior with respect to the composite outcome of acute rejection, graft and patient survival as compared to a combination of twice-daily immediate release tacrolimus and mycophenolate mofetil/mycophenolic acid.

Official Title

SIMPLE Study: A Prospective and Randomized Trial of a Simplified Immunosuppressive Protocol Utilizing Low Dose EnvarsusXR

Quick Facts

Study Start:2021-11-23
Study Completion:2025-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04773392

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 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * De- Novo Kidney transplant patients between 18 and 85 years old
  2. * Cold ischemia time (CIT) \< 24 hours for 3-6 HLA mismatches between donor and recipient and CIT \>24 hours for HLA mismatch of less than 3 between donor and recipient
  3. * Most recent pre-transplant cPRA (calculated panel reactive antibody) ≤ 20%
  1. * Repeat kidney transplant recipients
  2. * cPRA \>20%
  3. * rATG (rabbit anti-thymocyte globulin) induction \>6mg/kg at time of induction
  4. * Crossmatches deemed positive by accepting physician
  5. * Presence of pre-formed anti-HLA (anti-Human Leukocyte Antigen) DSA (Donor-Specific Antibody) as defined by MFI (mean fluorescence intensity) approaching 3000 using flow cytometry/Luminex-based, specific anti-HLA antibody testing.
  6. * Receipt of desensitization protocols
  7. * History of skin cancer
  8. * Recipient of multi-organ or dual kidney transplants
  9. * For any condition, in which the investigator's opinion makes the subject unsuitable for study

Contacts and Locations

Study Contact

Melissa Ramos, BSN
CONTACT
323-442-7983
Melissa.Ramos@med.usc.edu

Principal Investigator

Santhi Voora, MD
PRINCIPAL_INVESTIGATOR
University of Southern California

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90033
United States

Collaborators and Investigators

Sponsor: University of Southern California

  • Santhi Voora, MD, PRINCIPAL_INVESTIGATOR, University of Southern California

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 Date2021-11-23
Study Completion Date2025-02

Study Record Updates

Study Start Date2021-11-23
Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

  • tacrolimus
  • envarsus XR
  • kidney transplant
  • rejection
  • immunosuppressive agents
  • renal transplant

Additional Relevant MeSH Terms

  • Kidney Transplantation
  • Kidney Transplant Rejection