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NCT04566055 Clinical Trial

Assessing AlloSure Dd-cfDNA Monitoring Insights of Renal Allografts With Longitudinal Surveillance

Kidney Transplant Rejection Clinical Trial

— ADMIRAL  

Official title:
Assessing AlloSure Dd-cfDNA Monitoring Insights of Renal Allografts With Longitudinal Surveillance

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04566055
Other study ID # ADMIRAL
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date October 1, 2020

Study information
Verified date September 2020
Source CareDx
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1000
Est. completion date October 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Renal transplant patients

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• AlloSure
Patients will receive donor-derived cell-free DNA testing for surveillance and for-cause.

Locations
Country Name City State
United States University of Colorado Hospital Aurora Colorado
United States University of Maryland Baltimore Maryland
United States Memorial Hermann Hosptial Houston Texas
United States University of Minnesota Medical Center Minneapolis Minnesota
United States Intermountain Medical Center Murray Utah
United States Virginia Commonwealth University Richmond Virginia
United States Washington University Saint Louis Missouri
United States Tampa General Hosptial Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
CareDx

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Validation of AlloSure in Allograft rejection October 2020
Secondary 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
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