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Diagnostic Test

Primary donor-derived cell-free DNA for Kidney Transplant Rejection (KOAR Trial)

N/A
Waitlist Available
Research Sponsored by CareDx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up dec-2022
Awards & highlights

Summary

This trial is to study a new way to care for kidney transplant patients using a test called AlloSure. The test is designed to help doctors determine if a patient is rejecting their transplant and whether or not they need a biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dec-2022
This trial's timeline: 3 weeks for screening, Varies for treatment, and dec-2022 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Estimated glomerular filtration rate
Patient and graft survival
Serum creatinine
+1 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Secondary donor-derived cell-free DNAExperimental Treatment1 Intervention
1200 patients without planned renal surveillance biopsies at 12 months post-transplantation
Group II: Secondary KidneyCare®Experimental Treatment3 Interventions
1200 patients without planned renal surveillance biopsies at 12 months post-transplantation
Group III: Primary donor-derived cell-free DNAExperimental Treatment1 Intervention
300 patients with planned renal surveillance biopsies at 12 months post-transplantation
Group IV: Primary KidneyCare®Experimental Treatment3 Interventions
300 patients with planned renal surveillance biopsies at 12 months post-transplantation
Group V: ControlExperimental Treatment1 Intervention
A matched control cohort of 1000 patients with planned renal surveillance biopsies at 12 months post-transplantation but were not managed with donor-derived cell-free DNA (AlloSure®) or KidneyCare will be retrospectively selected

Find a Location

Who is running the clinical trial?

CareDxLead Sponsor
25 Previous Clinical Trials
11,444 Total Patients Enrolled
~404 spots leftby Jun 2025
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