An observational study in Kidney Transplant Rejection, sponsored by CareDx. Completed at 18 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-11-03.
Sponsored by CareDx · Observational
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.
CareDx is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Kidney transplant patients who are having their transplant follow-up care in community nephrology
Exclusion Criteria:
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
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.
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
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.
Time frame: 5 years
Assessment of kidney function
Relative change in eGFR from baseline in groups monitored using AlloSure compared to matched control group.
Time frame: 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.
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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