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Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation | Clinical Trials | Clareo Health

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Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation

Circulating Donor-Derived Cell-free DNA in Blood for Diagnosing Acute Rejection in Kidney Transplant Recipients

NCT02424227•CareDx

Summary

This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant

Detailed Description

This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant periodically and also after the treatment of acute rejection up to 8 weeks post treatment. The blood samples and all relevant clinical data will be provided to CareDx scientists for laboratory assay of dd-cfDNA levels and correlation of dd-cfDNA levels with the clinical features of the subjects. The primary objective of the study is to correlate circulating dd-cfDNA to clinical and sub-clinical acute rejection in renal allograft recipients. The secondary objective of the study is to correlate circulating dd-cfDNA to renal function, both serum creatinine and estimated glomerular filtration rate \[eGFR\]).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult recipients (Age \> 18 years )
•2. Both genders and all racial and ethnic groups
•3. Kidney transplant alone
•4. Both living and deceased donor transplants
•5. Primary and re-transplants. A total of 30 re-transplant recipients across all study sites will be eligible for enrollment. CareDx will notify all centers when this subset of enrollment has been met. Thereafter, all enrolled patients should be primary transplant recipients.
•6. Ability to come for follow-up and undergo biopsy (Performed in accordance to SOC)
•7. Ability to give written informed consent prior to study enrollment
•Patients can be enrolled at any time; before or after transplantation and/or at time of outpatient or inpatient visits for workup of medical problems; e.g. at the time of a renal biopsy (regardless of elapsed time since post transplant) as specified in this study protocol.

Exclusion Criteria

•1. Pediatric recipients (Age \< 18 years)
•2. Pregnant women
•3. Patients undergoing multi-organ transplants (e.g. kidney with pancreas or liver)
•4. Patients receiving donor organ from an identical twin

Locations (14)

University of Alabama, Birmingham

Birmingham, Alabama, United States

University of California Los Angeles

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Indiana University

Indianapolis, Indiana, United States

University of Maryland

Baltimore, Maryland, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University

St Louis, Missouri, United States

Columbia University

New York, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

University of Pennsylvannia

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 1, 2015

Primary Completion Date

August 30, 2018

Completion Date

January 31, 2019

Last Updated

December 17, 2018

Enrollment

401

ACTUAL participants

Conditions

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation

Inclusion Criteria

Exclusion Criteria

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