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 Type
OBSERVATIONAL
Enrollment
248
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
Amicis Research Center
Fairfield, California, United States
The Medical Research Group - Fresno
Fresno, California, United States
Amicis Research Center
Granada Hills, California, United States
Amicis Research Center
Mission Hills, California, United States
California Institute of Renal Research (Balboa)
San Diego, California, United States
Starling Physicians
Hartford, Connecticut, United States
George Washington/Medical Faculty Associates Inc.
Washington D.C., District of Columbia, United States
Physician Consultants of Georgia
Macon, Georgia, United States
NANI Research
Hinsdale, Illinois, United States
NANI Research
Fort Wayne, Indiana, United States
...and 8 more locations
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.