Molecular Biomarkers in Renal Transplantation Via TruGraf® Test

NCT ID: NCT04398498

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-13
• Study Completion Date: 2022-11-30

Brief Summary

The TruGraf® test is a non-invasive blood test that measures molecular gene expression profiles associated with clinical conditions previously only diagnosed by biopsy in kidney transplant recipients. The results of the TruGraf test provide additional information about the adequacy of immunosuppression and may be used to support decisions in patient management.

Detailed Description

This is a single-center, prospective, randomized study to evaluate clinical utility of TruGraf testing in patients with the following characteristics:1.Stable serum creatinine: current serum creatinine <2.3 mg/dl, <20% increase compare to the average of the previous 3 serum creatinine levels2.Kidney transplant patients who are:•more than 60 days post-transplant will be included in this study (Study A) •more than 2-yearspost-transplant but less than 5 years post-transplant (>24 months but < 60 months) will be included in this study (Study B) Scripps will enroll subjects who are post-transplant and are undergoing routine management. In Study A, patients will receive testing eight times: Month 2 (at time of surveillance biopsy) 6(at time of surveillance biopsy), 9, 12(at time of surveillance biopsy), 15, 18, 21 and 24(at time of surveillance biopsy) (plus or minus two weeks). Results of the genomic analysis will be considered in determining patient treatment plans and as a molecular guide to perform a surveillance biopsy. Clinical data elements using the Scripps EHR and cost of care will be collected for all subjects. In Study B, patients who are at least 2 years post transplant up to 5 years post-transplant will receive testing 8 times: Months 3 ,6, 9, 12, 15, 18, 21 and 24 (plus or minus two weeks)from the time of enrollment into the study. Results of the genomic analysis will be considered in determining patient treatment plans and whether any change is needed, such as whether to perform a surveillance biopsy. Clinical data elements using the Scripps EHR and cost of care will be collected for all subjects. We expect Study A to be completed 24-30months and Study B to be completed in 24-30 months.

Conditions

Kidney Transplant Rejection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort A: Clinical Practice

Subjects more than 60 days post-transplant

Diagnostic Test: TruGraf® Testing

Intervention Type: DIAGNOSTIC_TEST

5 mL collection PAXgene blood sample

Cohort B: Long Term Follow-Up

Subjects who are at least 2 years post transplant up to 5 years post-transplant

Diagnostic Test: TruGraf® Testing

Intervention Type: DIAGNOSTIC_TEST

5 mL collection PAXgene blood sample

Interventions

Diagnostic Test: TruGraf® Testing

5 mL collection PAXgene blood sample

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Peripheral blood gene expression profiling

Eligibility Criteria

Inclusion Criteria

• Recipient of a primary or subsequent deceased-donor or living donor kidney transplantation.
• Stable serum creatinine (current serum creatinine <2.3 mg/dl, <20% increase compared to the average of the previous 3 serum creatinine levels).
• Kidney transplant patients who are: > 60 days post-transplant (Cohort A); > 2-years post-transplant (Cohort B)

Exclusion Criteria

• Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
• Recipients of previous non-renal solid organ and/or islet cell transplantation.
• Infection with HIV.
• Infection with BK.
• Patients that have nephritic proteinuria (urine protein >3 gm/day).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scripps Health

OTHER

Sponsor Role: collaborator

Transplant Genomics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patty West-Thielke, PharmD

Role: STUDY_DIRECTOR

Transplant Genomics, Inc.

Locations

Scripps Clinic

La Jolla, California, United States

Countries

United States

References

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Other Identifiers

TGRP05-US005

Identifier Type: -

Identifier Source: org_study_id