Recruiting

TruGraf Test

Sponsor:

Transplant Genomics, Inc.

Code:

NCT04670926

Conditions

Kidney Transplant Rejection

Immunosuppression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TruGraf

Standard of Care

Study Details

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.

Conditions

Kidney Transplant Rejection

Immunosuppression

Study ID

NCT04670926

Start date

Jun 3, 2021

Status verified date

Aug, 2021

Completion date

Sep 30, 2023

Anticipated

Primary completion date

Jun 3, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Physicians decided to reduce immunosuppression [ Time Frame: Baseline to month 12 ]
  • Banff pathology [ Time Frame: Baseline to month 12 ]
  • Cost of patient care [ Time Frame: Baseline to month 12 ]

Central Contacts and Locations

Central contacts

Cortney C Miller, PhD

5107753326cortneymiller@eurofins-tgi.com

Isioma Agboli, MD

5107678609isiomaagboli@eurofins-tgi.com

Locations

California Pacific Medical Center

Recruiting

San Francisco, California, United States, 94115

Contacts

Ram Peddi

415-600-1063peddir@sutterhealth.org

More Information

Sponsor

Transplant Genomics, Inc.

Last update posted

Aug 27, 2021

Last verified

Aug, 2021

Keywords

  • kidney transplant
  • immunosuppression
  • biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Transplant Genomics, Inc. on 2021-08-27.