Assessing AlloSure Dd-cfDNA Monitoring Insights of Renal Allografts With Longitudinal Surveillance
- Conditions
- Kidney Transplant Rejection
- Interventions
- Device: AlloSure
- Registration Number
- NCT04566055
- Lead Sponsor
- CareDx
- Brief Summary
Prospective Observational Multicenter Cohort. External validation of donor derived cell free DNA in Renal Transplantation. Assessing performance of dd-cfDNA as a surveillance tool and its association with clinical outcomes. Outcomes include formation of de-novo DSA, eGFR decline, performance of AlloSure dd-cfDNA in Allograft rejection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- Renal transplant patients
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective observational cohort AlloSure -
- Primary Outcome Measures
Name Time Method Validation of AlloSure in Allograft rejection October 2020
- Secondary Outcome Measures
Name Time Method Performance of AS with De-Novo DSAs, Performance in subclinical and protocol biopsies vs clinically indicated for cause biopsies, Survival analysis considering AS surveillance October 2020
Trial Locations
- Locations (8)
Intermountain Medical Center
🇺🇸Murray, Utah, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Memorial Hermann Hosptial
🇺🇸Houston, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Tampa General Hosptial
🇺🇸Tampa, Florida, United States