Status:
UNKNOWN
Immunosuppression Management in Renal Transplant Recipients With Transplant Excellence Based on TruGraf Test
Lead Sponsor:
Transplant Genomics, Inc.
Collaborating Sponsors:
California Pacific Medical Center
Conditions:
Kidney Transplant Rejection
Immunosuppression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an investigator-initiated, single-center, prospective, randomized, proof of concept study. In this study patients who are status post kidney transplantation and meet the inclusion and exclusio...
Detailed Description
The study will consist of 2 parts (Part-I and Part-II). In Part I of the study, kidney transplant recipients who are low-risk for rejection and meet the inclusion and exclusion criteria for study Part...
Eligibility Criteria
Inclusion
- Part-I
- Patients who meet all of the following criteria are eligible for enrollment:
- All males or females of at least 18 years of age.
- Have the ability to understand the requirements of the study and are able to provide written informed consent.
- Recipient of a primary deceased-donor or living donor kidney transplant.
- Patients at low-immunological risk for acute rejection defined as cPRA of less than 50; no DSA; non-African American recipients
- HLA crossmatch negative (virtual cross match acceptable)
- Allograft from a deceased donor with KDPI \< 50%
Exclusion
- Patients who meet any of the following criteria are not eligible for enrollment:
- Inability or unwillingness to provide informed consent.
- Need for combined organ transplantation with an extra-renal organ transplant.
- Recipients of previous non-renal solid organ and/or islet cell transplantation.
- Infection with HIV
- Patients with Hepatitis B or C PCR positive.
- Patients on corticosteroids at the time of transplantation
- Patients with leucopenia (WBC \<3.0) and thrombocytopenia (platelets \<100)
- Patients who will NOT receive Thymoglobulin induction (\>4.5 mg/kg total dose)
- HLA-identical living related renal transplant recipients
- Part-II
- Inclusion Criteria: Patients who meet all of the following criteria are eligible for enrollment:
- Stable serum creatinine level and estimated eGFR of \> 45 mL/min at 90 days post-transplantation
- Kidney transplant patients who are more than 90 days post-transplant.
- Patients who have received Thymoglobulin induction therapy (\> 4.5 mg/kg) and tolerated corticosteroid withdrawal.
Key Trial Info
Start Date :
June 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04670926
Start Date
June 3 2021
End Date
September 30 2023
Last Update
August 27 2021
Active Locations (1)
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1
California Pacific Medical Center
San Francisco, California, United States, 94115