Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR

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.

Conditions

Kidney Transplantation, Kidney Transplant Rejection

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Study Overview

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Study Details

Study overview

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.

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

Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR

Condition
Kidney Transplantation
Intervention / Treatment

-

Contacts and Locations

Los Angeles

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * De- Novo Kidney transplant patients between 18 and 85 years old
  • * 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
  • * Most recent pre-transplant cPRA (calculated panel reactive antibody) ≤ 20%
  • * Repeat kidney transplant recipients
  • * cPRA \>20%
  • * rATG (rabbit anti-thymocyte globulin) induction \>6mg/kg at time of induction
  • * Crossmatches deemed positive by accepting physician
  • * 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.
  • * Receipt of desensitization protocols
  • * History of skin cancer
  • * Recipient of multi-organ or dual kidney transplants
  • * For any condition, in which the investigator's opinion makes the subject unsuitable for study

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Southern California,

Santhi Voora, MD, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

2025-02