Kidney Transplant RejectionNCT04491552
TruGraf® Long-term Clinical Outcomes Study
An observational study of Kidney Transplant Rejection, run by Transplant Genomics, Inc. at 36 sites in United States.
Trial summary
This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. 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?
- Patients monitored with TruGraf and TRAC testing
- How many people
- 2,000 participants
- Where
- 36 sitesUnited States
- Study dates
- 9 Sep 2020to Nov 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This study is an observational study in adult (age ≥ 18 years), kidney transplant patients who are at least one year from the time of transplant. Approximately 2000 subjects will be enrolled.
Who may be able to join
- Written informed consent and HIPAA authorization;
- At least 18 years of age;
- Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
- At least 3-months post-transplant;
- Stable serum creatinine (per Principal Investigator);
- Treated with any immunosuppressive regimen, and;
- Selected by provider to undergo OmniGraf™ (TruGraf® and TRAC™) testing as part of post-transplant care; and
Who cannot join
- Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant;
- Recipient of a previous non-renal solid organ and/or islet cell transplant;
- Known to be pregnant;
- Known to be infected with HIV;
- Known to have Active BK nephropathy;
- Known to have nephrotic proteinuria (Per Principal Investigator);
- Participation in other biomarker studies testing clinical utility.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites, 36 recruiting
- Recruiting
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87106
Primary Coordinator, dlsedillo@salud.unm.edu
- Recruiting
Universtiy of Maryland Medical Center
Baltimore, Maryland, 21201
Primary Coordinator, maheen.khan@som.umaryland.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Primary Coordinator, ADUROCHER2@mgh.harvard.edu
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Primary Coordinator, smcderm2@bidmc.harvard.edu
- Recruiting
Erie County Medical Center
Buffalo, New York, 14215
Primary Coordinator, msacilowsk@ecmc.edu
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Primary Coordinator, saundert@musc.edu
- Recruiting
Northwestern University
Chicago, Illinois, 60208
Study Coordinator, a-daud@northwestern.edu
- Recruiting
University of Illinois-Chicago Medical Center
Chicago, Illinois, 60612
Primary Coordinator, kbruno@uic.edu
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Primary Coordinator, grimml@ccf.org
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Primary Coordinator, Morgan.Marsh@UTSouthwestern.edu
- Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Study Coordinator, lori.schlegel@inova.org
- Recruiting
Fresno Nephrology Medical Group
Fresno, California, 93720
Primary Coordinator, ngill@themedicalresearchgroup.com
- Recruiting
Vidant Medical Center
Greenville, North Carolina, 27834
Study Coordinator, apontet21@ecu.edu
- Recruiting
Clinical Research Strategies
Houston, Texas, 77030
Primary Coordinator, sonny@kidneydocs.org
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Primary Coordinator, edelaney2@kumc.edu
- Recruiting
Scripps Memorial Hospital La Jolla
La Jolla, California, 92037
Primary Coordinator, barrick.bethany@scrippshealth.org
- Recruiting
Keck Hospital of USC
Los Angeles, California, 90033
Primary Coordinator, esther.park@med.usc.edu
- Recruiting
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112
Primary Coordinator, dbartho@tulane.edu
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Primary Coordinator, katie.ostlund@unmc.edu
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Primary Coordinator, jarrod.goodarz@pennmedicine.upenn.edu
- Recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Primary Coordinator, sally.quinn@tuhs.temple.edu
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Primary Coordinator, joyce.ruddley@vcuhealth.org
- Recruiting
House of Transplant and Cancer- Riverside Community Hospital
Riverside, California, 92501
Primary Coordinator, payam.javaherizadeh@hcahealthcare.com
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14618
Study Coordinator, Allison_Stewart@URMC.Rochester.edu
- Recruiting
UR Medicine Strong Memorial Hospital
Rochester, New York, 14642
Primary Coordinator, allison_stewart@urmc.rochester.edu
- Recruiting
University of California Davis
Sacramento, California, 95817
Primary Coordinator, khowes@ucdavis.edu
- Recruiting
Utah Kidney Research Institute
Salt Lake City, Utah, 84115
Clinical Research Manager, ukrinephrology@gmail.com
- Recruiting
University of Utah Hospital
Salt Lake City, Utah, 84132
Primary Coordinator, Amber.lamph@hsc.utah.edu
- Recruiting
California Pacific Medical Center
San Francisco, California, 94109
Primary Coordinator, razavirf@sutterhealth.org
- Recruiting
Primary Coordinator
Seattle, Washington, 98195
Primary Coordinator, nidhim3@Nephrology.washington.edu
- Recruiting
Willis-Knighton Medical Center
Shreveport, Louisiana, 71103
Primary Coordinator, sstephens2@wkhs.com
- Recruiting
Renal and Transplant Associates of New England
Springfield, Massachusetts, 01107
Primary Coordinator, JWhitbeck@rtane.org
- Recruiting
Primary Coordinator Coordinator
St Louis, Missouri, 63110
Primary Coordinator Coordinator, devinwall@wustl.edu
Primary Coordinator, aomar@wustl.edu
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Primary Coordinator, OMOHAMME@montefiore.org
- Recruiting
Banner University Medical Center Tucson
Tucson, Arizona, 85724
Primary Coordinator, stephm1@arizona.edu
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Primary Coordinator, ALYSSA.STUCKE@georgetown.edu
About this study
This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.
Read the detailed description
Several studies have validated TruGraf® in stable renal transplant patients to rule out subclinical acute rejection. These studies generally evaluated the diagnostic value of TruGraf® at single timepoints. Thus the value of serial monitoring and changes over time has not been previously investigated. In addition, no study has assessed TruGraf® and TRAC™in a serial and longitudinal fashion.
Therefore the aim of this study is to evaluate the impact of serial monitoring renal transplant patients with both TruGraf® and TRAC™ on long term outcomes.
- Conditions
- Kidney Transplant Rejection
- Being tested
- Patients monitored with TruGraf and TRAC testing
- Keywords
- Biomarkers, Subclinical Rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients monitored with TruGraf and TRAC testingDiagnostic test
This is an observational study there are no protocol mandated interventions. TruGraf and TRAC results will be utilized in conjunction with standard of care assessments to determine patient management.
| Study group | Role | What they receive |
|---|---|---|
| Patients monitored with TruGraf and TRAC testing | Subjects will have TruGraf and TRAC testing at study enrollment (Baseline) and thereafter every 3 months. In addition subjects will have TRAC testing at any time there is a suspicion of acute rejection. Receives: Diagnostic Test: Patients monitored with TruGraf and TRAC testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of either biopsy proven acute rejection (BPAR) on a for cause biopsy or graft loss, or a decrease from baseline in eGFR > 10 mL/min.
Measured: Baseline to month 24
Secondary outcomes (13)
First occurrence of biopsy proven acute rejection (on a for cause biopsy)
Measured: Baseline to month 24
First occurrence of clinically treated acute rejection
Measured: Baseline to month 24
Proteinuria
defined by a spot urine protein-creatinine ratio > 0.5
Measured: Baseline to month 24
TruGraf results
The proportion of TruGraf not-TX results
Measured: Baseline to month 24
TRAC results
The proportion of TRAC results > 0.69
Measured: Baseline to month 24
Clinical Utility of TruGraf and TRAC in clinical decision making
Percent of total number of TruGraf results that the PI identified as having clinical utility
Measured: Baseline to month 24
Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA)
Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA)
Measured: Baseline to month 24
Proportion of subjects with graft loss
defined as permanent return to dialysis, retransplantation or patient death at any time during the 2-year primary follow-up study period
Measured: Baseline to month 24
Graft survival
calculated from the date of kidney transplantation until data of graft loss
Measured: Baseline to month 24
Proportion of subjects with death-censored graft loss
defined as permanent return to dialysis or retransplantation at any time during the 2-year primary follow-up study period. Patients who die with a functioning graft will be right censored
Measured: Baseline to month 24
Percent subject death period
Subject death from any cause at any time
Measured: Baseline to month 24
Subject survival
calculated from date of kidney transplantation until date of patient death
Measured: Baseline to month 24
Estimated GFR
calculated using the MDRD 4-variable equation
Measured: Baseline to month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start9 Sep 2020
- Primary completionSep 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transplant Genomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patty W. Thielke, PharmD, Principal investigator, Transplant Genomics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491552
- Sponsor's protocol ID
- TGRP06
- Status last verified
- Nov 2022
- First submitted
- 23 Jul 2020
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D, Klarenbach S, Gill J. Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant. 2011 Oct;11(10):2093-109. doi: 10.1111/j.1600-6143.2011.03686.x. Epub 2011 Aug 30.
PubMed 21883901Hart A, Smith JM, Skeans MA, Gustafson SK, Stewart DE, Cherikh WS, Wainright JL, Boyle G, Snyder JJ, Kasiske BL, Israni AK. Kidney. Am J Transplant. 2016 Jan;16 Suppl 2(Suppl 2):11-46. doi: 10.1111/ajt.13666.
PubMed 26755262Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378-83. doi: 10.1111/j.1600-6143.2004.00332.x.
PubMed 14961990Rush D, Nickerson P, Gough J, McKenna R, Grimm P, Cheang M, Trpkov K, Solez K, Jeffery J. Beneficial effects of treatment of early subclinical rejection: a randomized study. J Am Soc Nephrol. 1998 Nov;9(11):2129-34. doi: 10.1681/ASN.V9112129.
PubMed 9808101El Ters M, Grande JP, Keddis MT, Rodrigo E, Chopra B, Dean PG, Stegall MD, Cosio FG. Kidney allograft survival after acute rejection, the value of follow-up biopsies. Am J Transplant. 2013 Sep;13(9):2334-41. doi: 10.1111/ajt.12370. Epub 2013 Jul 19.
PubMed 23865852Loupy A, Vernerey D, Tinel C, Aubert O, Duong van Huyen JP, Rabant M, Verine J, Nochy D, Empana JP, Martinez F, Glotz D, Jouven X, Legendre C, Lefaucheur C. Subclinical Rejection Phenotypes at 1 Year Post-Transplant and Outcome of Kidney Allografts. J Am Soc Nephrol. 2015 Jul;26(7):1721-31. doi: 10.1681/ASN.2014040399. Epub 2015 Jan 2.
PubMed 25556173First MR, Pierry, D, McNultuy, M et al. Analytical and clinical validation of a molecular diagnostic signature in kidney transplant recipients. J Transplant. Technol. Res. 2017; 7(3).
US Renal Data System. 2016 USRDS annual data report: Epidemiology of kidney disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2016.
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 30979456Snyder TM, Khush KK, Valantine HA, Quake SR. Universal noninvasive detection of solid organ transplant rejection. Proc Natl Acad Sci U S A. 2011 Apr 12;108(15):6229-34. doi: 10.1073/pnas.1013924108. Epub 2011 Mar 28.
PubMed 21444804De Vlaminck I, Martin L, Kertesz M, Patel K, Kowarsky M, Strehl C, Cohen G, Luikart H, Neff NF, Okamoto J, Nicolls MR, Cornfield D, Weill D, Valantine H, Khush KK, Quake SR. Noninvasive monitoring of infection and rejection after lung transplantation. Proc Natl Acad Sci U S A. 2015 Oct 27;112(43):13336-41. doi: 10.1073/pnas.1517494112. Epub 2015 Oct 12.
PubMed 26460048Gielis EM, Ledeganck KJ, De Winter BY, Del Favero J, Bosmans JL, Claas FH, Abramowicz D, Eikmans M. Cell-Free DNA: An Upcoming Biomarker in Transplantation. Am J Transplant. 2015 Oct;15(10):2541-51. doi: 10.1111/ajt.13387. Epub 2015 Jul 16.
PubMed 26184824Sharon E, Shi H, Kharbanda S, Koh W, Martin LR, Khush KK, Valantine H, Pritchard JK, De Vlaminck I. Quantification of transplant-derived circulating cell-free DNA in absence of a donor genotype. PLoS Comput Biol. 2017 Aug 3;13(8):e1005629. doi: 10.1371/journal.pcbi.1005629. eCollection 2017 Aug.
PubMed 28771616
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TruGraf® Long-term Clinical Outcomes Study
- ClinicalTrials.gov ID
- NCT04491552
- Acronym / sponsor ID
- TGRP06
- Conditions
- Kidney Transplant Rejection
- Keywords
- Biomarkers, Subclinical Rejection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Transplant Genomics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 29 Jul 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 a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.
Detailed description
Several studies have validated TruGraf® in stable renal transplant patients to rule out subclinical acute rejection. These studies generally evaluated the diagnostic value of TruGraf® at single timepoints. Thus the value of serial monitoring and changes over time has not been previously investigated. In addition, no study has assessed TruGraf® and TRAC™in a serial and longitudinal fashion.
Therefore the aim of this study is to evaluate the impact of serial monitoring renal transplant patients with both TruGraf® and TRAC™ on long term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients monitored with TruGraf and TRAC testing | – | Diagnostic Test: Patients monitored with TruGraf and TRAC testingSubjects will have TruGraf and TRAC testing at study enrollment (Baseline) and thereafter every 3 months. In addition subjects will have TRAC testing at any time there is a suspicion of acute rejection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is an observational study in adult (age ≥ 18 years), kidney transplant patients who are at least one year from the time of transplant. Approximately 2000 subjects will be enrolled.
Key inclusion criteria (7 listed)
- Written informed consent and HIPAA authorization;
- At least 18 years of age;
- Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
- At least 3-months post-transplant;
- Stable serum creatinine (per Principal Investigator);
Key exclusion criteria (7 listed)
- Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant;
- Recipient of a previous non-renal solid organ and/or islet cell transplant;
- Known to be pregnant;
- Known to be infected with HIV;
- Known to have Active BK nephropathy;
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 |
|---|---|---|
| Patients monitored with TruGraf and TRAC testingThis is an observational study there are no protocol mandated interventions. TruGraf and TRAC results will be utilized in conjunction with standard of care assessments to determine patient management. | Diagnostic test | Patients monitored with TruGraf and TRAC testing |
Primary outcome
occurrence of either biopsy proven acute rejection (BPAR) on a for cause biopsy or graft loss, or a decrease from baseline in eGFR > 10 mL/min.
Time frame: Baseline to month 24
13 secondary outcomes
First occurrence of biopsy proven acute rejection (on a for cause biopsy)
Time frame: Baseline to month 24
First occurrence of clinically treated acute rejection
Time frame: Baseline to month 24
Proteinuria
Time frame: Baseline to month 24
TruGraf results
Time frame: Baseline to month 24
TRAC results
Time frame: Baseline to month 24
Clinical Utility of TruGraf and TRAC in clinical decision making
Time frame: Baseline to month 24
Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA)
Time frame: Baseline to month 24
Proportion of subjects with graft loss
Time frame: Baseline to month 24
Graft survival
Time frame: Baseline to month 24
Proportion of subjects with death-censored graft loss
Time frame: Baseline to month 24
Percent subject death period
Time frame: Baseline to month 24
Subject survival
Time frame: Baseline to month 24
Estimated GFR
Time frame: Baseline to month 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Background: PubMed 21883901Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D, Klarenbach S, Gill J. Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant. 2011 Oct;11(10):2093-109. doi: 10.1111/j.1600-6143.2011.03686.x. Epub 2011 Aug 30.
- Background: PubMed 26755262Hart A, Smith JM, Skeans MA, Gustafson SK, Stewart DE, Cherikh WS, Wainright JL, Boyle G, Snyder JJ, Kasiske BL, Israni AK. Kidney. Am J Transplant. 2016 Jan;16 Suppl 2(Suppl 2):11-46. doi: 10.1111/ajt.13666.
- Background: PubMed 14961990Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378-83. doi: 10.1111/j.1600-6143.2004.00332.x.
- Background: PubMed 9808101Rush D, Nickerson P, Gough J, McKenna R, Grimm P, Cheang M, Trpkov K, Solez K, Jeffery J. Beneficial effects of treatment of early subclinical rejection: a randomized study. J Am Soc Nephrol. 1998 Nov;9(11):2129-34. doi: 10.1681/ASN.V9112129.
- Background: PubMed 23865852El Ters M, Grande JP, Keddis MT, Rodrigo E, Chopra B, Dean PG, Stegall MD, Cosio FG. Kidney allograft survival after acute rejection, the value of follow-up biopsies. Am J Transplant. 2013 Sep;13(9):2334-41. doi: 10.1111/ajt.12370. Epub 2013 Jul 19.
- Background: PubMed 25556173Loupy A, Vernerey D, Tinel C, Aubert O, Duong van Huyen JP, Rabant M, Verine J, Nochy D, Empana JP, Martinez F, Glotz D, Jouven X, Legendre C, Lefaucheur C. Subclinical Rejection Phenotypes at 1 Year Post-Transplant and Outcome of Kidney Allografts. J Am Soc Nephrol. 2015 Jul;26(7):1721-31. doi: 10.1681/ASN.2014040399. Epub 2015 Jan 2.
- BackgroundFirst MR, Pierry, D, McNultuy, M et al. Analytical and clinical validation of a molecular diagnostic signature in kidney transplant recipients. J Transplant. Technol. Res. 2017; 7(3).
- BackgroundUS Renal Data System. 2016 USRDS annual data report: Epidemiology of kidney disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2016.
- 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 21444804Snyder TM, Khush KK, Valantine HA, Quake SR. Universal noninvasive detection of solid organ transplant rejection. Proc Natl Acad Sci U S A. 2011 Apr 12;108(15):6229-34. doi: 10.1073/pnas.1013924108. Epub 2011 Mar 28.
- Background: PubMed 26460048De Vlaminck I, Martin L, Kertesz M, Patel K, Kowarsky M, Strehl C, Cohen G, Luikart H, Neff NF, Okamoto J, Nicolls MR, Cornfield D, Weill D, Valantine H, Khush KK, Quake SR. Noninvasive monitoring of infection and rejection after lung transplantation. Proc Natl Acad Sci U S A. 2015 Oct 27;112(43):13336-41. doi: 10.1073/pnas.1517494112. Epub 2015 Oct 12.
- Background: PubMed 26184824Gielis EM, Ledeganck KJ, De Winter BY, Del Favero J, Bosmans JL, Claas FH, Abramowicz D, Eikmans M. Cell-Free DNA: An Upcoming Biomarker in Transplantation. Am J Transplant. 2015 Oct;15(10):2541-51. doi: 10.1111/ajt.13387. Epub 2015 Jul 16.
- 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 W. Thielke, PharmD principal investigator
Transplant Genomics, Inc.
36 sites 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 36 sites 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isioma Agboli, MD (510-767-8609, isiomaagboli@eurofins-tgi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of either biopsy proven acute rejection (BPAR) on a for cause biopsy or graft loss, or a decrease from baseline in eGFR > 10 mL/min. (time frame: Baseline to month 24). 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 NCT04491552, which also lists 13 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 14 Nov 2022.