Kidney Transplant RejectionNCT04267016
Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care
An observational study of Kidney Transplant Rejection, run by Transplant Genomics, Inc. at 1 site in United States.
Trial summary
This is an observational study in renal transplant recipients to evaluate the acceptability, feasibility, and clinical utility of TruGraf® testing in conjunction with standard clinical assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- TruGraf Testing - Peripheral blood gene expression profiling
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2020to 11 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All eligible renal transplant recipients who meet the inclusion/exclusion criteria will be part of this study.
Who may be able to join
- 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 >90 days (+/- 2 weeks) post-transplant will be included in this study
Who cannot join
- 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 nephropathy.
- Patients that have nephrotic proteinuria (urine protein >3 gm/day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Pilot Study to Test the Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care
This is an observational study in renal transplant recipients to evaluate the acceptability, feasibility, and clinical utility of TruGraf® testing in conjunction with standard clinical assessment. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.
- Conditions
- Kidney Transplant Rejection
- Being tested
- TruGraf Testing - Peripheral blood gene expression profiling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruGraf Testing - Peripheral blood gene expression profilingDiagnostic test
Also called Standard of care
5 mL collection PAXgene blood sample
| Study group | Role | What they receive |
|---|---|---|
| All Subjects Enrolled | Renal transplant recipients who are undergoing routine management Receives: Diagnostic Test: TruGraf Testing - Peripheral blood gene expression profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Utility of TruGraf Results
Percent of total number of TruGraf results that the PI identified as having clinical utility
Measured: through study completion, an average of 6 months
Correlation of TruGraf Results
Percent of total number of TruGraf results that the PI identified as being correlated to other clinical results obtained through the standard of care.
Measured: through study completion, an average of 6 months
Feasibility of TruGraf Testing
Percent of total number of eligible subjects for whom the PI was able to complete the entire TruGraf testing workflow
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start19 Aug 2020
- Primary completion11 May 2021
- Study completion11 May 2021
Why it stopped: Sponsor decision to cancel study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transplant Genomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Patty West-Thielke, PharmD, Study director, Transplant Genomics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267016
- Sponsor's protocol ID
- TGRP01-US001
- Status last verified
- Sep 2021
- First submitted
- 6 Feb 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marsh CL, Kurian SM, Rice JC, Whisenant TC, David J, Rose S, Schieve C, Lee D, Case J, Barrick B, Peddi VR, Mannon RB, Knight R, Maluf D, Mandelbrot D, Patel A, Friedewald JJ, Abecassis MM, First MR. Application of TruGraf v1: A Novel Molecular Biomarker for Managing Kidney Transplant Recipients With Stable Renal Function. Transplant Proc. 2019 Apr;51(3):722-728. doi: 10.1016/j.transproceed.2019.01.054. Epub 2019 Jan 26.
PubMed 30979456First MR, Peddi VR, Mannon R, Knight R, Marsh CL, Kurian SM, Rice JC, Maluf D, Mandelbrot D, Patel A, David J, Schieve C, Lee D, Lewis P, Friedewald JJ, Abecassis MM, Rose S. Investigator Assessment of the Utility of the TruGraf Molecular Diagnostic Test in Clinical Practice. Transplant Proc. 2019 Apr;51(3):729-733. doi: 10.1016/j.transproceed.2018.10.024. Epub 2018 Dec 11.
PubMed 30979457
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pilot Study to Test the Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care
- ClinicalTrials.gov ID
- NCT04267016
- Acronym / sponsor ID
- TGRP01-US001
- Conditions
- Kidney Transplant Rejection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision to cancel study
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Transplant Genomics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study in renal transplant recipients to evaluate the acceptability, feasibility, and clinical utility of TruGraf® testing in conjunction with standard clinical assessment. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects Enrolled | – | Diagnostic Test: TruGraf Testing - Peripheral blood gene expression profilingRenal transplant recipients who are undergoing routine management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All eligible renal transplant recipients who meet the inclusion/exclusion criteria will be part of this study.
Key inclusion criteria (3 listed)
- 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 >90 days (+/- 2 weeks) post-transplant will be included in this study
Key exclusion criteria (5 listed)
- 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 nephropathy.
- Patients that have nephrotic proteinuria (urine protein >3 gm/day).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TruGraf Testing - Peripheral blood gene expression profilingAlso: Standard of care5 mL collection PAXgene blood sample | Diagnostic test | All Subjects Enrolled |
Primary outcome
Clinical Utility of TruGraf Results
Time frame: through study completion, an average of 6 months
Percent of total number of TruGraf results that the PI identified as having clinical utility
Correlation of TruGraf Results
Time frame: through study completion, an average of 6 months
Percent of total number of TruGraf results that the PI identified as being correlated to other clinical results obtained through the standard of care.
Feasibility of TruGraf Testing
Time frame: through study completion, an average of 6 months
Percent of total number of eligible subjects for whom the PI was able to complete the entire TruGraf testing workflow
Results and safety
The study was stopped early (reason given: Sponsor decision to cancel study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 30979456Marsh CL, Kurian SM, Rice JC, Whisenant TC, David J, Rose S, Schieve C, Lee D, Case J, Barrick B, Peddi VR, Mannon RB, Knight R, Maluf D, Mandelbrot D, Patel A, Friedewald JJ, Abecassis MM, First MR. Application of TruGraf v1: A Novel Molecular Biomarker for Managing Kidney Transplant Recipients With Stable Renal Function. Transplant Proc. 2019 Apr;51(3):722-728. doi: 10.1016/j.transproceed.2019.01.054. Epub 2019 Jan 26.
- Background: PubMed 30979457First MR, Peddi VR, Mannon R, Knight R, Marsh CL, Kurian SM, Rice JC, Maluf D, Mandelbrot D, Patel A, David J, Schieve C, Lee D, Lewis P, Friedewald JJ, Abecassis MM, Rose S. Investigator Assessment of the Utility of the TruGraf Molecular Diagnostic Test in Clinical Practice. Transplant Proc. 2019 Apr;51(3):729-733. doi: 10.1016/j.transproceed.2018.10.024. Epub 2018 Dec 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patty West-Thielke, PharmD study director
Transplant Genomics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Rejection, run by Transplant Genomics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision to cancel study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Utility of TruGraf Results (time frame: through study completion, an average of 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04267016, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.