Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR
Launched by UNIVERSITY OF SOUTHERN CALIFORNIA · Feb 25, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new way to prevent kidney transplant rejection in patients who have just received a kidney. Researchers want to see if using a medication called EnvarsusXR, taken once a day, along with another drug called Azathioprine, works just as well as a more traditional treatment that involves taking two different medications twice a day. The goal is to find out if this simpler approach can help patients avoid rejection of the transplanted kidney and ensure both the kidney and the patient stay healthy.
To be part of this study, participants should be between 18 and 85 years old and have just received their first kidney transplant. There are certain conditions regarding how long the kidney was without blood flow before the transplant and specific antibody levels that must be met to qualify. If someone joins the trial, they can expect to be closely monitored to see how well this new treatment works for them. Overall, this study aims to find a more straightforward and effective way to manage kidney transplant care.
Gender
ALL
Eligibility criteria
- Inclusion 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%
- Exclusion Criteria:
- • 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
About University Of Southern California
The University of Southern California (USC) is a prestigious research institution located in Los Angeles, California, known for its commitment to advancing knowledge and innovation in various fields, including medicine and health sciences. As a clinical trial sponsor, USC leverages its extensive resources, interdisciplinary expertise, and state-of-the-art facilities to conduct cutting-edge research aimed at improving patient outcomes and public health. The university fosters collaboration among its diverse faculty and students, ensuring a dynamic environment for the development and implementation of clinical studies that adhere to the highest ethical and scientific standards. Through its clinical trials, USC aims to contribute to the advancement of medical science and the translation of research findings into practical applications that benefit communities locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Patients applied
Trial Officials
Santhi Voora, MD
Principal Investigator
University of Southern California
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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