Transition of Renal Patients Using AlloSure Into Community Kidney Care

Study Overview
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Brief Summary
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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.

Official Title
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Transition of Renal Patients Using AlloSure Into Community Kidney Care

Conditions
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Kidney Transplant Rejection

Intervention / Treatment
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* Device: AlloSure


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AlloSure Group<br>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<br>* 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<br>|
| Control Group<br>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?
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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 |