Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation (DART)

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ClinicalTrials.gov Identifier: NCT02424227

Recruitment Status : Active, not recruiting

First Posted : April 22, 2015

Last Update Posted : December 17, 2018

Sponsor:

Information provided by (Responsible Party):

CareDx

Study Description

Brief 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

Condition or disease
Kidney Transplant Recipients

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]).

Study Design

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Study Type :	Observational
Actual Enrollment :	401 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Circulating Donor-Derived Cell-free DNA in Blood for Diagnosing Acute Rejection in Kidney Transplant Recipients
Study Start Date :	April 2015
Actual Primary Completion Date :	August 30, 2018
Estimated Study Completion Date :	January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Transplantation

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Kidney Transplant Recipients Adult living and deceased donor kidney transplant recipients will be eligible to participate in this study.

Outcome Measures

Primary Outcome Measures :

Clinical T cell as well as antibody mediated acute rejection [ Time Frame: Occurring within 12 months post transplant ]
Sub-clinical T cell as well as antibody mediated acute rejection [ Time Frame: Occurring within 12 months post transplant ]
Composite of clinical and sub-clinical T cell as well as antibody mediated acute rejection [ Time Frame: Occurring within 12 months post transplant ]

Secondary Outcome Measures :

eGFR (estimated Glomerular Filtration Rate [mL/min]): will be derived from serum creatinine level, corrected for variables, using the CKD-RPI (Chronic Kidney Disease Epidemiology Collaboration) equation [ Time Frame: 24 months ]
Renal allograft injury from BKV nephritis, CNI toxicity, acute pyeloenephrtiis and recurrent disease confirmed by renal histology [ Time Frame: 24 months ]

Biospecimen Retention: Samples With DNA

cfDNA samples collected in Cell-Free DNA BCT and mRNA collected in PAX gene tubes will be retained

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult de novo living and deceased donor kidney transplant recipients will be eligible to participate in this study.

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424227

Locations

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United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California Los Angeles
Los Angeles, California, United States, 90024
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvannia
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor Research Institute
Fort Worth, Texas, United States, 76104
Baylor Scott and White
Temple, Texas, United States, 76502

Sponsors and Collaborators

CareDx

Investigators

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Study Director:	James Yee, MD	CareDx

More Information

Publications:

Haas M, Sis B, Racusen LC, Solez K, Glotz D, Colvin RB, Castro MC, David DS, David-Neto E, Bagnasco SM, Cendales LC, Cornell LD, Demetris AJ, Drachenberg CB, Farver CF, Farris AB 3rd, Gibson IW, Kraus E, Liapis H, Loupy A, Nickeleit V, Randhawa P, Rodriguez ER, Rush D, Smith RN, Tan CD, Wallace WD, Mengel M; Banff meeting report writing committee. Banff 2013 meeting report: inclusion of c4d-negative antibody-mediated rejection and antibody-associated arterial lesions. Am J Transplant. 2014 Feb;14(2):272-83. doi: 10.1111/ajt.12590. Erratum in: Am J Transplant. 2015 Oct;15(10):2784. Rangel, Erika [corrected to Rangel, Erika B].

Lo YM. Transplantation monitoring by plasma DNA sequencing. Clin Chem. 2011 Jul;57(7):941-2. doi: 10.1373/clinchem.2011.166686.

Snyder TM, Khush KK, Valantine HA, Quake SR. Universal noninvasive detection of solid organ transplant rejection. Proc Natl Acad Sci U S A. 2011 Apr 12;108(15):6229-34. doi: 10.1073/pnas.1013924108. Epub 2011 Mar 28.

Code of Federal Regulations, Title 42 - Public Health, Part 493 - Laboratory Requirements, Subpart A - General Provisions, Sections 1, 2 & 3

Hidestrand M, Tomita-Mitchell A, Hidestrand PM, Oliphant A, Goetsch M, Stamm K, Liang HL, Castleberry C, Benson DW, Stendahl G, Simpson PM, Berger S, Tweddell JS, Zangwill S, Mitchell ME. Highly sensitive noninvasive cardiac transplant rejection monitoring using targeted quantification of donor-specific cell-free deoxyribonucleic acid. J Am Coll Cardiol. 2014 Apr 1;63(12):1224-1226. doi: 10.1016/j.jacc.2013.09.029. Epub 2013 Oct 16.

Sigdel TK, Vitalone MJ, Tran TQ, Dai H, Hsieh SC, Salvatierra O, Sarwal MM. A rapid noninvasive assay for the detection of renal transplant injury. Transplantation. 2013 Jul 15;96(1):97-101. doi: 10.1097/TP.0b013e318295ee5a.

De Vlaminck I, Valantine HA, Snyder TM, Strehl C, Cohen G, Luikart H, Neff NF, Okamoto J, Bernstein D, Weisshaar D, Quake SR, Khush KK. Circulating cell-free DNA enables noninvasive diagnosis of heart transplant rejection. Sci Transl Med. 2014 Jun 18;6(241):241ra77. doi: 10.1126/scitranslmed.3007803.

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Responsible Party:	CareDx
ClinicalTrials.gov Identifier:	NCT02424227
Other Study ID Numbers:	SN-C-00006
First Posted:	April 22, 2015 Key Record Dates
Last Update Posted:	December 17, 2018
Last Verified:	December 2018

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