Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:January 23, 2018
End Date:December 31, 2022
Contact:Quynh Tran
Email:qtran@caredx.com
Phone:415-287-2309

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This is an observational study to evaluate safety and efficacy outcomes in renal transplant
recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a
non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is
intended to assess the probability of allograft rejection in kidney transplant recipients
with clinical suspicion of rejection and to inform clinical decision-making regarding the
necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction
with standard clinical assessment.

The AlloSure test has been approved for Medicare coverage for clinical use when a physician
determines there is a need to assess the probability of allograft rejection in kidney
transplant recipients. Accurate and timely detection of allograft rejection and effective
treatment are essential for long-term survival of renal transplants. The DART study validated
the ability of the non-invasive AlloSure test to measure donor-derived cell-free DNA
(dd-cfDNA) to discriminate active rejection in a renal transplant recipient. Use of the test
will inform and may reduce invasive percutaneous renal biopsy procedures among patients with
risk of rejection.

KOAR Inclusion Criteria:

1. Medicare-covered (Part B) renal transplant recipients selected by their providers to
receive AlloSure testing as part of their practical care beginning by 2 months
post-transplantation.

2. Patient's health care provider adopts and intends to apply the center's AlloSure
Routine Testing Schedule as part of the information used to manage the patient.

3. Subjects willing to provide written informed consent to participate.

KOAR Exclusion Criteria:

1. Renal transplant recipients without Medicare (Part B) coverage.

___________________________________________________________

Exclusions for AlloSure® Intended Use

Specimens from patients for whom any of the following are true will not be tested:

1. Recipients of transplanted organs other than kidney

2. Recipients of a transplant from a monozygotic (identical)

3. Recipients of a bone marrow transplant

4. Recipients who are pregnant

5. Recipients who are under the age of 18

6. Recipient who are less than 14 days post-transplant
We found this trial at
47
sites
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Jeffrey Klein, MD
Phone: 913-588-3520
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Daniel Brennan, MD
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: David Wojciechowski, DO
Phone: 617-643-6266
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Boston, MA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Amtul Aala, MD
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Enver Akalin, MD
Phone: 347-671-8217
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
Principal Investigator: Mariana Markell, MD
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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Brooklyn, NY
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Pratik Shah, MD
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Stuart Knechtle, MD
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: James B Piper, MD
Phone: 703-776-3505
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Falls Church, VA
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Iasmina Craici, MD
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Edmund Huang, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Thin Thin Maw, MD
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Suphamai Bunnapradist, MD
Phone: 310-794-8516
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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1611 Northwest 12th Avenue
Miami, Florida 33136
Principal Investigator: George Burke, MD
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Miami, FL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Anthony Langone, MD
Phone: 615-936-1182
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Roy Bloom, MD
Phone: 215-615-0773
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Reginald Gohh, MD
Phone: 401-444-8598
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Sacramento, California 95814
Principal Investigator: Yihung Huang, MD
Phone: 916-734-4009
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Fuad Shihab, MD
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Victor Bowers, MD
Phone: 813-844-5692
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Tampa, FL
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Erik Stites, MD
Phone: 303-724-3978
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Aurora, CO
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Jonathan Bromberg, MD
Phone: 410-328-0303
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Oyedolamu Olaitan, MD
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Emilio Poggio, MD
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Columbus, Ohio 43210
Principal Investigator: Reem Daloul, MD
Phone: 614-293-4665
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Dallas, Texas 75390
Principal Investigator: Malcolm MacConmara, MD
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Fort Worth, Texas 76104
Principal Investigator: Bernard Fischbach, MD
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521 Moye Boulevard
Greenville, North Carolina 27834
Principal Investigator: David Leeser, MD
Phone: 252-744-0114
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Livingston, New Jersey 07039
Principal Investigator: Anup Patel, MD
Phone: 973-322-5392
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Loma Linda, California 92354
Principal Investigator: Rafael Villicana, MD
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Loma Linda, CA
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Maywood, Illinois 60153
Principal Investigator: Amishi Desai, DO
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Minneapolis, Minnesota 55455
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Principal Investigator: Titte Srinivas, MD
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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New Orleans, Louisiana 70112
Principal Investigator: Anil Paramesh, MD
Phone: 504-988-2882
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New Orleans, Louisiana 70121
Principal Investigator: Zohreh Soltani, MD
Phone: 504-703-5606
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Eric Langewisch, MD
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Puneet Sood, MD
Phone: 412-692-2207
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Dhiren Kumar, MD
Phone: 804-828-9684
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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Saint Louis, Missouri 63110
Principal Investigator: Tarek Alhamed, MD
Phone: 314-362-4109
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
Principal Investigator: Ram Peddi, MD
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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San Francisco, California 94143
Principal Investigator: Shiang-Cheng Kung, MD
Phone: 415-476-8695
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Spokane, Washington 99204
Principal Investigator: Samer BaniHani, MD
Phone: 509-474-4302
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2401 South 31st Street
Temple, Texas 76508
Principal Investigator: Mohanram Narayanan, MD
Phone: 254-935-5838
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Principal Investigator: Matthew Cooper, MD
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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Washington, District of Columbia 20052
Principal Investigator: Muralidharan Jagadeesan, MD
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