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Immunosuppression Management in Renal Transplant Recipients With Transplant Excellence Based on TruGraf Test

Sponsor
Transplant Genomics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04670926
Collaborator
California Pacific Medical Center (Other)
75
Enrollment
1
Location
2
Arms
27.9
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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 exclusion criteria will undergo immunosuppression reduction and will be followed closely to assess stability of graft function.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: TruGraf
  • Other: Standard of Care
 N/A

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-I will be approached for informed consent in the peri-transplant period, defined as 7 days before to 5 days after transplantation. Basic clinical history and kidney transplant function that are reviewed for routine transplant care are utilized to screen patients who are approached for study discussion and informed consent.

Patients who agree to participation in the study will have received Thymoglobulin induction of at least 4.5 mg/Kg body weight total dose. These patients will have their corticosteroids withdrawn by day 30 post-transplantation and will be followed with kidney function labs at least weekly through day-90 post-transplantation. Withdrawal of corticosteroids in patients who are immunologically at low risk for acute rejection similar to this study population and have received at least 4.5 mg/kg total dose of Thymoglobulin is standard practice. Patients meeting inclusion and exclusion criteria for Part-II of the study will continue with the study. Those failing to meet the inclusion/exclusion criteria for Part-II of the study will conclude the study and will be followed per CPMC standard of care.

In Part II, study patients will be randomized to one of the two groups in a 2:1 ratio. Two patients will be randomized to the study group for every one patient to the standard of care group. A total of 75 patients will be enrolled. Fifty to the study group and 25 to the standard of care group. The patients will have post transplantation follow-up labs as standard of care and clinic visits also as standard of care. There are no additional clinic visits for the study purposes or study procedures. TruGraf blood will be collected at the same time as the standard of care blood tests and additional phlebotomy is not required.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Immunosuppression Management in Renal Transplant Recipients With Transplant Excellence Based on TruGraf Test
Actual Study Start Date :
Jun 3, 2021
Anticipated Primary Completion Date :
Jun 3, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: TruGraf - Group 1:

Patients randomized to Group 1 will receive serial TruGraf testing at months 3, 4, 5, 6, 7, 8, 9, and 12. Results will be available in real-time and used by the physician to guide management of immunosuppression.

Diagnostic Test: TruGraf
TruGraf results will be available in real-time and used by the physician in conjunction with other standard of care labs to guide management of immunosuppression as follows: Patients with a stable serum creatinine and eGFR of > 45 mL/min who also have a TruGraf TX result at month 3 will have their Mycophenolate Mofetil or Mycophenolate Sodium decreased from a standard dose of 1000 mg twice daily to 500 mg twice daily or 720 mg twice daily to 360 mg twice daily respectively. Patients with a stable serum creatinine and estimated eGFR of > 45 mL/min who also have a TruGraf TX result at months 4, 5, and 6 will have their Tacrolimus target trough level decreased to a target between 3 and 6. Patients with TruGraf not-TX will have no further immunosuppression reduction and continued to be monitored.
Other Names:
  • TruGraf Blood Gene Expression Test

    		•
    Active Comparator: CPMC Standard of Care - Group 2:

    Patients randomized to Group 2 or CPMC Standard of Care Group patients will have current standard of care laboratory assessments.

    Other: Standard of Care
    Patient's immunosuppression will be managed per the current CPMC standard of care that includes continuation of Mycophenolate Mofetil or Mycopheonolate Sodium at 1000 mg bid or 720 mg bid respectively. The dose may be decreased at the discretion of the physician for drug adverse effects such as diarrhea or other gastrointestinal side-effects or neutropenia as is the standard of care. Patients will be maintained on Tacrolimus at target levels that are considered standard of care by the managing physician.

    Outcome Measures

    Primary Outcome Measures

    1. Physicians decided to reduce immunosuppression [Baseline to month 12]

      Percent or total number of patients who physicians decided could reduce immunosuppression.

    2. Banff pathology [Baseline to month 12]

      Banff pathology will be assessed for all study subjects receiving a biopsy during the study period (if performed).

    3. Cost of patient care [Baseline to month 12]

      The cost of patient care will be evaluated by measuring the total health care spending for health care services provided during the study period.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Part-I

    Inclusion Criteria: Patients who meet all of the following criteria are eligible for enrollment:

    1. All males or females of at least 18 years of age.

    2. Have the ability to understand the requirements of the study and are able to provide written informed consent.

    3. Recipient of a primary deceased-donor or living donor kidney transplant.

    4. Patients at low-immunological risk for acute rejection defined as cPRA of less than 50; no DSA; non-African American recipients

    5. HLA crossmatch negative (virtual cross match acceptable)

    6. Allograft from a deceased donor with KDPI < 50%

    Exclusion Criteria: Patients who meet any of the following criteria are not eligible for enrollment:

    1. Inability or unwillingness to provide informed consent.

    2. Need for combined organ transplantation with an extra-renal organ transplant.

    3. Recipients of previous non-renal solid organ and/or islet cell transplantation.

    4. Infection with HIV

    5. Patients with Hepatitis B or C PCR positive.

    6. Patients on corticosteroids at the time of transplantation

    7. Patients with leucopenia (WBC <3.0) and thrombocytopenia (platelets <100)

    8. Patients who will NOT receive Thymoglobulin induction (>4.5 mg/kg total dose)

    9. HLA-identical living related renal transplant recipients

    Part-II

    Inclusion Criteria: Patients who meet all of the following criteria are eligible for enrollment:

    1. Stable serum creatinine level and estimated eGFR of > 45 mL/min at 90 days post-transplantation

    2. Kidney transplant patients who are more than 90 days post-transplant.

    3. Patients who have received Thymoglobulin induction therapy (> 4.5 mg/kg) and tolerated corticosteroid withdrawal.

    Exclusion Criteria: Patients who meet any of these criteria are not eligible for enrollment:

    1. Infection with BK viremia with viral loads 10,000 copies/mL.

    2. Patients with proteinuria (urine protein >1 gm/gm of creatinine).

    3. Patients diagnosed with acute allograft rejection of any grade

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 California Pacific Medical Center San Francisco California United States 94115

    Sponsors and Collaborators

    • Transplant Genomics, Inc.
    • California Pacific Medical Center

    Investigators

    • Principal Investigator: Ram Peddi, California Pacific Medical Center
    • Study Director: Patty West-Thielke, PharmD, Eurofins-TGI

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Transplant Genomics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04670926
    Other Study ID Numbers:
    • TGRP07
    First Posted:
    Dec 17, 2020
    Last Update Posted:
    Aug 27, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Transplant Genomics, Inc.
    kidney transplant
    immunosuppression
    biomarkers

    Study Results

    No Results Posted as of Aug 27, 2021