NCT04601155

Transition of Renal Patients Using AlloSure Into Community Kidney Care

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 248 (actual)
• Sponsor: CareDx · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Kidney Transplant Rejection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-11-19
• Primary completion: 2023-03-24
• Completion: 2023-10-06
• First posted: 2020-10-23
• Last updated: 2023-11-03

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated device study