CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients

NCT05482100 | Not Yet Recruiting

• 1 other identifier: TGRP11
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, multi-site, observational study with a matched control group. The primary objective is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring.

Conditions

Kidney Transplant Rejection

Keywords

Biomarkers; Subclinical Rejection; Immunosuppression

Outcome Measures

Primary Outcomes (1)

• GFR changes between study group and matched control group

  Comparison of the slope change in estimated glomerular filtration rate (eGFR), calculated using the MDRD 4-variable equation and CKD-EPI, from baseline to the end of follow-up between study participants and a matched control group.

  3 years

Secondary Outcomes (13)

• PROMISE and Self efficacy results from baseline to study completion

  3 years

• PROMISE results from baseline to study completion

  3 years

• PROMIS Depression scale from baseline to study completion

  3 years

• Comparison of Hospitlizations due to infections in the matched control and study group

  3 years

• Comparison of rejection of matched control and study group

  3 years

Study Arms (1)

Patients monitored with OmniGraf Testing

Subjects will have OmniGraf™ testing at study enrollment and thereafter every 3 months or at the same time as standard routine labs (minimum two per year). In addition, subjects will have OmniGraf™ testing at any time there is a workup for clinical events and referral to advanced care (transplant center, biopsy, etc)

Diagnostic Test: Patients monitored with OmniGraf testing

Interventions

Patients monitored with OmniGraf testing DIAGNOSTIC_TEST

This is an observational study there are no protocol mandated interventions. OmniGraf results will be utilized in conjunction with standard of care assessments to determine patient management.

Patients monitored with OmniGraf Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is an observational study in adult (age ≥ 18 years), kidney transplant patients who are at 3 months to 2 years from the time of transplant. Approximately 500 subjects will be enrolled.

You may qualify if:

• 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;
• Between 3 months and 2 years post-transplant;
• Selected by provider to undergo OmniGraf™ testing as part of usual post-transplant care

You may not qualify if:

• 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 Human Immunodeficiency Virus (HIV);
• Known to have active BK nephropathy;
• Known to have nephrotic proteinuria (per principal investigator); or
• Participation in other biomarker studies

Sponsors & Collaborators

• Transplant Genomics, Inc.: lead

Related Publications (12)

• 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.

  PMID: 21883901 BACKGROUND

• Saran R, Robinson B, Abbott KC, Agodoa LY, Albertus P, Ayanian J, Balkrishnan R, Bragg-Gresham J, Cao J, Chen JL, Cope E, Dharmarajan S, Dietrich X, Eckard A, Eggers PW, Gaber C, Gillen D, Gipson D, Gu H, Hailpern SM, Hall YN, Han Y, He K, Hebert H, Helmuth M, Herman W, Heung M, Hutton D, Jacobsen SJ, Ji N, Jin Y, Kalantar-Zadeh K, Kapke A, Katz R, Kovesdy CP, Kurtz V, Lavalee D, Li Y, Lu Y, McCullough K, Molnar MZ, Montez-Rath M, Morgenstern H, Mu Q, Mukhopadhyay P, Nallamothu B, Nguyen DV, Norris KC, O'Hare AM, Obi Y, Pearson J, Pisoni R, Plattner B, Port FK, Potukuchi P, Rao P, Ratkowiak K, Ravel V, Ray D, Rhee CM, Schaubel DE, Selewski DT, Shaw S, Shi J, Shieu M, Sim JJ, Song P, Soohoo M, Steffick D, Streja E, Tamura MK, Tentori F, Tilea A, Tong L, Turf M, Wang D, Wang M, Woodside K, Wyncott A, Xin X, Zang W, Zepel L, Zhang S, Zho H, Hirth RA, Shahinian V. US Renal Data System 2016 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2017 Mar;69(3 Suppl 1):A7-A8. doi: 10.1053/j.ajkd.2016.12.004. No abstract available.

  PMID: 28236831 BACKGROUND

• Hart 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.

  PMID: 26755262 BACKGROUND

• Meier-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.

  PMID: 14961990 BACKGROUND

• Lentine KL, Smith JM, Hart A, Miller J, Skeans MA, Larkin L, Robinson A, Gauntt K, Israni AK, Hirose R, Snyder JJ. OPTN/SRTR 2020 Annual Data Report: Kidney. Am J Transplant. 2022 Mar;22 Suppl 2:21-136. doi: 10.1111/ajt.16982.

  PMID: 35266618 BACKGROUND

• El-Zoghby ZM, Stegall MD, Lager DJ, Kremers WK, Amer H, Gloor JM, Cosio FG. Identifying specific causes of kidney allograft loss. Am J Transplant. 2009 Mar;9(3):527-35. doi: 10.1111/j.1600-6143.2008.02519.x. Epub 2008 Feb 3.

  PMID: 19191769 BACKGROUND

• Arms MA, Fleming J, Sangani DB, Nadig SN, McGillicuddy JW, Taber DJ. Incidence and impact of adverse drug events contributing to hospital readmissions in kidney transplant recipients. Surgery. 2018 Feb;163(2):430-435. doi: 10.1016/j.surg.2017.09.027. Epub 2017 Nov 22.

  PMID: 29174434 BACKGROUND

• Couzi L, Moulin B, Morin MP, Albano L, Godin M, Barrou B, Alamartine E, Morelon E, Girardot-Seguin S, Mendes L, Misdrahi D, Cassuto E, Merville P. Factors predictive of medication nonadherence after renal transplantation: a French observational study. Transplantation. 2013 Jan 27;95(2):326-32. doi: 10.1097/TP.0b013e318271d7c1.

  PMID: 23149477 BACKGROUND

• Gonzales HM, Fleming JN, Gebregziabher M, Posadas-Salas MA, Su Z, McGillicuddy JW, Taber DJ. Pharmacist-Led Mobile Health Intervention and Transplant Medication Safety: A Randomized Controlled Clinical Trial. Clin J Am Soc Nephrol. 2021 May 8;16(5):776-784. doi: 10.2215/CJN.15911020. Epub 2021 Apr 30.

  PMID: 33931415 BACKGROUND

• Park S, Guo K, Heilman RL, Poggio ED, Taber DJ, Marsh CL, Kurian SM, Kleiboeker S, Weems J, Holman J, Zhao L, Sinha R, Brietigam S, Rebello C, Abecassis MM, Friedewald JJ. Combining Blood Gene Expression and Cellfree DNA to Diagnose Subclinical Rejection in Kidney Transplant Recipients. Clin J Am Soc Nephrol. 2021 Oct;16(10):1539-1551. doi: 10.2215/CJN.05530421.

  PMID: 34620649 BACKGROUND

• Kalantar-Zadeh K, Kam-Tao Li P, Tantisattamo E, Kumaraswami L, Liakopoulos V, Lui SF, Ulasi I, Andreoli S, Balducci A, Dupuis S, Harris T, Hradsky A, Knight R, Kumar S, Ng M, Poidevin A, Saadi G, Tong A; World Kidney Day Steering Committee. Living well with kidney disease by patient and care-partner empowerment: kidney health for everyone everywhere. Kidney Int. 2021 Feb;99(2):278-284. doi: 10.1016/j.kint.2020.11.004.

  PMID: 33509344 BACKGROUND

• Fleming JN, Cober T, Hickey J, Stach L, Kawano A, Szczepanik A, Watson A, Imamura Y, Weems J, West-Thielke P. Clinical Utility of the OmniGraf Biomarker Panel in the Care of Kidney Transplant Recipients (CLARITY): Protocol for a Prospective, Multisite Observational Study. JMIR Res Protoc. 2022 Dec 14;11(12):e41020. doi: 10.2196/41020.

  PMID: 36515980 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood and Urine

Study Officials

• Patty West-Thielke, PharmD

  Transplant Genomics

  STUDY DIRECTOR

Central Study Contacts

Isioma Agboli, MD

CONTACT

15107678609; isiomaagboli@eurofins-tgi.com

James Fleming, PharmD

CONTACT

JamesFleming@eurofins-tgi.com

Study Design

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

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: August 1, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share