Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation

Status unconfirmed

Conditions studied: Kidney Transplant Recipients

In brief

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

Key facts

Study ID

NCT02424227

Run by

CareDx

People needed

401

Starts

2015-04-01

Expected to finish

2019-01-31

Last updated by the study team

2018-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult recipients (Age > 18 years )
• Both genders and all racial and ethnic groups
• Kidney transplant alone
• Both living and deceased donor transplants
• 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.
• Ability to come for follow-up and undergo biopsy (Performed in accordance to SOC)
• 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.

You may not qualify if…

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

Where it is running

• 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
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor Research Institute — Fort Worth, Texas, United States
• Baylor Scott and White — Temple, Texas, United States

Full record on ClinicalTrials.gov

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