Clinical trial NCT04670926: Immunosuppression Management in Renal Transplant Recipients With Transplant Excellence Based on TruGraf Test
Official title: Immunosuppression Management in Renal Transplant Recipients With Transplant Excellence Based on TruGraf Test
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplant Rejection
Immunosuppression
Keywords: kidney transplant
immunosuppression
biomarkers
Lead sponsor: Transplant Genomics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: California Pacific Medical Center
First posted: 2020-12-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.

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 These patients will have their corticosteroids withdrawn by day 30 post-transplantation and will be followed with kidney function labs at least weekly through day-90 post-transplantation.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.

Eligibility criteria: 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

Primary outcomes:
measure: Physicians decided to reduce immunosuppression
timeFrame: Baseline to month 12
measure: Banff pathology
timeFrame: Baseline to month 12
measure: Cost of patient care
timeFrame: Baseline to month 12
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
Study officials:
affiliation: California Pacific Medical Center
name: Ram Peddi
role: PRINCIPAL_INVESTIGATOR
affiliation: Eurofins-TGI
name: Patty West-Thielke, PharmD
role: STUDY_DIRECTOR
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