Transition of Renal Patients Using AlloSure Into Community Kidney Care

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.

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Key information

Conditions

Kidney Transplant Rejection

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amicis Research Center, Fairfield, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

AlloSure

Device

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

Primary outcomes

Superior allograft survival

Time frame: 5 years

Time to allograft loss, defined as composite of: return to dialysis, re-transplant, death due to allograft failure, and death with functioning allograft.

Secondary outcomes

Assessment of kidney function

Time frame: 5 years

Relative change in eGFR from baseline in groups monitored using AlloSure compared to matched control group.
Assessment of immunologic status

Time frame: 5 years

Proportion of patients with formation of de-novo DSA antibodies in groups monitored using AlloSure compared to matched control group.

Sponsors and collaborators

Lead sponsor

CareDx

Industry

Registry information

Acronym: TRACK

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Oct 23, 2020
Registry last updated: Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed