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

NCT04670926 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-08-27

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • California Pacific Medical Center

    collaborator OTHER

  • Transplant Genomics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ram Peddi · California Pacific Medical Center

  • Patty West-Thielke, PharmD · Eurofins-TGI

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2023-06-03
Completion
2023-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04670926 on ClinicalTrials.gov