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

NCT04670926 | Unknown FDA Device

• 1 other identifier: TGRP07
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

kidney transplant; immunosuppression; biomarkers

Outcome Measures

Primary Outcomes (3)

• Physicians decided to reduce immunosuppression

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

  Baseline to month 12

• Banff pathology

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

  Baseline to month 12

• Cost of patient care

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

  Baseline to month 12

Study Arms (2)

TruGraf - Group 1:

EXPERIMENTAL

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

CPMC Standard of Care - Group 2:

ACTIVE COMPARATOR

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

Other: Standard of Care

Interventions

TruGraf DIAGNOSTIC_TEST

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.

Also known as: TruGraf Blood Gene Expression Test

TruGraf - Group 1:

Standard of Care OTHER

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.

CPMC Standard of Care - Group 2:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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
• 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.
• Infection with BK viremia with viral loads 10,000 copies/mL.
• Patients with proteinuria (urine protein \>1 gm/gm of creatinine).

Sponsors & Collaborators

• Transplant Genomics, Inc.: lead
• California Pacific Medical Center: collaborator

Study Sites (1)

California Pacific Medical Center

San Francisco, California, 94115, United States

RECRUITING

Related Publications (24)

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MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ram Peddi

  California Pacific Medical Center

  PRINCIPAL INVESTIGATOR

• Patty West-Thielke, PharmD

  Eurofins-TGI

  STUDY DIRECTOR

Central Study Contacts

Cortney C Miller, PhD

CONTACT

5107753326; cortneymiller@eurofins-tgi.com

Isioma Agboli, MD

CONTACT

5107678609; isiomaagboli@eurofins-tgi.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: June 3, 2021
• Primary Completion: June 3, 2023
• Study Completion: September 30, 2023
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)