NCT04398498

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

2.6 years

First QC Date

May 8, 2020

Last Update Submit

August 13, 2021

Conditions

Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (7)

  • Cohort A: Percent or total number of patients who physicians decided could forego a surveillance biopsy due to TruGraf results

    12 months post-transplant

  • Cohort A: Percent or total number of patients who physicians decided could forego a surveillance biopsy due to TruGraf results

    24 months post-transplant

  • Cohort A: Correlation of TruGraf test results with surveillance biopsy

    2 years

  • Cohort A and B: Banff pathology

    Banff pathology will be assessed and compared to TruGraf results.

    2 years

  • Cohort A and B: Renal graft function

    Renal graft function will be assessed by measuring Estimated Glomerular Filtration Rate (eGFR).

    2 years

  • Cohort A and B: Renal graft function

    Renal graft function will be assessed by measuring serum creatinine (sCr) levels.

    2 years

  • Cohort A and B: 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.

    2 years

Secondary Outcomes (2)

  • Incidence of death

    2 years

  • Incidence of graft loss

    2 years

Study Arms (2)

Cohort A: Clinical Practice

Subjects more than 60 days post-transplant

Diagnostic Test: Diagnostic Test: TruGraf® Testing

Cohort B: Long Term Follow-Up

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

Diagnostic Test: Diagnostic Test: TruGraf® Testing

Interventions

Diagnostic Test: TruGraf® TestingDIAGNOSTIC_TEST

5 mL collection PAXgene blood sample

Also known as: Peripheral blood gene expression profiling
Cohort A: Clinical PracticeCohort B: Long Term Follow-Up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Kidney transplant recipients

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Clinic

La Jolla, California, 92037, United States

Location

Related Publications (15)

  • Rana A, Gruessner A, Agopian VG, Khalpey Z, Riaz IB, Kaplan B, Halazun KJ, Busuttil RW, Gruessner RW. Survival benefit of solid-organ transplant in the United States. JAMA Surg. 2015 Mar 1;150(3):252-9. doi: 10.1001/jamasurg.2014.2038.

    PMID: 25629390BACKGROUND

  • Matas AJ, Gillingham KJ, Humar A, Kandaswamy R, Sutherland DE, Payne WD, Dunn TB, Najarian JS. 2202 kidney transplant recipients with 10 years of graft function: what happens next? Am J Transplant. 2008 Nov;8(11):2410-9. doi: 10.1111/j.1600-6143.2008.02414.x.

    PMID: 18925907BACKGROUND

  • Lamb KE, Lodhi S, Meier-Kriesche HU. Long-term renal allograft survival in the United States: a critical reappraisal. Am J Transplant. 2011 Mar;11(3):450-62. doi: 10.1111/j.1600-6143.2010.03283.x. Epub 2010 Oct 25.

    PMID: 20973913BACKGROUND

  • Montgomery RA. One kidney for life. Am J Transplant. 2014 Jul;14(7):1473-4. doi: 10.1111/ajt.12772. Epub 2014 May 9. No abstract available.

    PMID: 24816339BACKGROUND

  • Matas AJ, Smith JM, Skeans MA, Thompson B, Gustafson SK, Stewart DE, Cherikh WS, Wainright JL, Boyle G, Snyder JJ, Israni AK, Kasiske BL. OPTN/SRTR 2013 Annual Data Report: kidney. Am J Transplant. 2015 Jan;15 Suppl 2:1-34. doi: 10.1111/ajt.13195.

    PMID: 25626344BACKGROUND

  • Waldmann H. Drug minimization in transplantation: an opinion. Curr Opin Organ Transplant. 2014 Aug;19(4):331-3. doi: 10.1097/MOT.0000000000000099. No abstract available.

    PMID: 24991978BACKGROUND

  • Racusen LC, Solez K, Colvin RB, Bonsib SM, Castro MC, Cavallo T, Croker BP, Demetris AJ, Drachenberg CB, Fogo AB, Furness P, Gaber LW, Gibson IW, Glotz D, Goldberg JC, Grande J, Halloran PF, Hansen HE, Hartley B, Hayry PJ, Hill CM, Hoffman EO, Hunsicker LG, Lindblad AS, Yamaguchi Y, et al. The Banff 97 working classification of renal allograft pathology. Kidney Int. 1999 Feb;55(2):713-23. doi: 10.1046/j.1523-1755.1999.00299.x.

    PMID: 9987096BACKGROUND

  • Rush 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.

    PMID: 9808101BACKGROUND

  • Nankivell BJ, Chapman JR. The significance of subclinical rejection and the value of protocol biopsies. Am J Transplant. 2006 Sep;6(9):2006-12. doi: 10.1111/j.1600-6143.2006.01436.x. Epub 2006 Jun 22.

    PMID: 16796717BACKGROUND

  • Legendre C, Thervet E, Skhiri H, Mamzer-Bruneel MF, Cantarovich F, Noel LH, Kreis H. Histologic features of chronic allograft nephropathy revealed by protocol biopsies in kidney transplant recipients. Transplantation. 1998 Jun 15;65(11):1506-9. doi: 10.1097/00007890-199806150-00020.

    PMID: 9645814BACKGROUND

  • Seron D, Moreso F. Protocol biopsies in renal transplantation: prognostic value of structural monitoring. Kidney Int. 2007 Sep;72(6):690-7. doi: 10.1038/sj.ki.5002396. Epub 2007 Jun 27.

    PMID: 17597702BACKGROUND

  • Heilman RL, Devarapalli Y, Chakkera HA, Mekeel KL, Moss AA, Mulligan DC, Mazur MJ, Hamawi K, Williams JW, Reddy KS. Impact of subclinical inflammation on the development of interstitial fibrosis and tubular atrophy in kidney transplant recipients. Am J Transplant. 2010 Mar;10(3):563-70. doi: 10.1111/j.1600-6143.2009.02966.x. Epub 2010 Feb 1.

    PMID: 20121731BACKGROUND

  • Rush DN, Henry SF, Jeffery JR, Schroeder TJ, Gough J. Histological findings in early routine biopsies of stable renal allograft recipients. Transplantation. 1994 Jan;57(2):208-11. doi: 10.1097/00007890-199401001-00009.

    PMID: 8310509BACKGROUND

  • Kirk AD, Jacobson LM, Heisey DM, Radke NF, Pirsch JD, Sollinger HW. Clinically stable human renal allografts contain histological and RNA-based findings that correlate with deteriorating graft function. Transplantation. 1999 Nov 27;68(10):1578-82. doi: 10.1097/00007890-199911270-00024.

    PMID: 10589958BACKGROUND

  • Moreso F, Ibernon M, Goma M, Carrera M, Fulladosa X, Hueso M, Gil-Vernet S, Cruzado JM, Torras J, Grinyo JM, Seron D. Subclinical rejection associated with chronic allograft nephropathy in protocol biopsies as a risk factor for late graft loss. Am J Transplant. 2006 Apr;6(4):747-52. doi: 10.1111/j.1600-6143.2005.01230.x.

    PMID: 16539631BACKGROUND

Study Officials

  • Patty West-Thielke, PharmD

    Transplant Genomics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 21, 2020

Study Start

April 13, 2020

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)