Transition of Renal Patients Using AlloSure Into Community Kidney Care (TRACK)

Patients undergoing kidney transplantation alone (either de-novo or re-transplant) at a participating hospital are routinely surveyed with interval blood tests as part of standard post-operative care through outpatient consultation. These tests include serum creatinine, blood sugar as well as DSA testing at various intervals. The ability to screen patients to better identify those who may be at risk of developing an adverse event using AlloSure cfDNA is likely to be advantageous, with the potential to improve graft survival and outcomes for transplant patients. The addition of AlloSure to the interventional group will be the focus of this study. Patients will have quarterly AlloSure cfDNA testing (every 3 months) and DSA as part of their post-transplant surveillance for a period of 5 years.Participants will attend outpatient visits/follow-up visits as part of their standard care, these will include appointments where they will have blood tests taken as part of post-transplant surveillance. For AlloSure cfDNA and DSA, blood will be taken quarterly.

Study Overview

• Status: Completed
• Conditions: Kidney Transplant Rejection
• Intervention / Treatment: Device: AlloSure

• Study Type: Observational
• Enrollment (Actual): 248

Contacts and Locations

Study Locations

• United States
  • California
    • Fairfield, California, United States, 94533
      • Amicis Research Center
    • Fresno, California, United States, 93720
      • The Medical Research Group - Fresno
    • Granada Hills, California, United States, 91344
      • Amicis Research Center
    • Mission Hills, California, United States, 91345
      • Amicis Research Center
    • San Diego, California, United States, 92123
      • California Institute of Renal Research (Balboa)
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Starling Physicians
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington/Medical Faculty Associates Inc.
  • Georgia
    • Macon, Georgia, United States, 31201
      • Physician Consultants of Georgia
  • Illinois
    • Hinsdale, Illinois, United States, 60521
      • NANI Research
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • NANI Research
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • Manhasset, New York, United States, 11030
      • PRINE Health
    • New York, New York, United States, 10013
      • Chinatown Kidney
    • Queens, New York, United States, 11355
      • Nephrology Associates PC, Queens
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Sholer Chris MD
  • Utah
    • South Ogden, Utah, United States, 84403
      • Utah Kidney Research Institute
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Lynchburg Nephrology Physicians, PLLC
    • Woodbridge, Virginia, United States, 22192
      • Mendez Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant patients who are having their transplant follow-up care in community nephrology

Description

Inclusion Criteria:

• Participants with single kidney transplant (de-novo or re-transplant) who are ≥ 6 months and ≤ 36 months post-transplant. Participants and will need to have a draw in this time period .
• Participant is willing and able to give informed consent for participation in the trial.
• Male or Female, aged 12 years or older.
• In the Investigator's opinion, is able and willing to comply with all trial requirements.

Exclusion Criteria:

• Participant who is pregnant, lactating or planning pregnancy during the trial.
• Significant hepatic impairment (determined by the PI).
• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
• Participant with life expectancy of less than 6 months, or inappropriate for diagnostic monitoring through regular blood sampling.
• < 6 months and > 36 months post-transplant
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
• Multi-organ transplant (e.g., Kidney-Pancreas).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AlloSure Group; Patients will have quarterly AlloSure cfDNA testing (every 3 months) and DSA as part of their post-transplant surveillance for a period of 5 years. For the quarterly AlloSure tests, approximately 20 mL of blood will be obtained in Streck Cell-Free DNA BCT tubes and shipped to CareDx, Inc. (Brisbane, CA) to analyze the presence of donor-derived cell-free DNA.	Device: AlloSure; AlloSure is an analytically validated targeted next-generation sequencing (NGS) assay that uses single-nucleotide polymorphisms (SNPs) to measure the fraction of dd-cfDNA in transplant patients without the need for genotyping either the donor or the recipient.8
Control Group; The control group was never followed with AlloSure as part of their post-transplant follow-up care. Matched control data will originate from UNOS SRTR data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superior allograft survival	Time to allograft loss, defined as composite of: return to dialysis, re-transplant, death due to allograft failure, and death with functioning allograft.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of kidney function	Relative change in eGFR from baseline in groups monitored using AlloSure compared to matched control group.	5 years
Assessment of immunologic status	Proportion of patients with formation of de-novo DSA antibodies in groups monitored using AlloSure compared to matched control group.	5 years

Collaborators and Investigators

• Sponsor: CareDx
• Investigators: Study Director: Chris Boshkos, CareDx

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Actual): March 24, 2023
• Study Completion (Actual): October 6, 2023

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SN-C-00012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes