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Kidney Transplant RecipientsDARTNCT02424227

Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation

An observational study of Kidney Transplant Recipients, run by CareDx at 14 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplant Recipients
How many people
401 participants
Where
14 sitesUnited States
Study dates
Apr 2015to 31 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • University of Maryland

    Baltimore, Maryland, 21201

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35294

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Baylor Research Institute

    Fort Worth, Texas, 76104

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of California Los Angeles

    Los Angeles, California, 90024

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of Minnesota

    Minneapolis, Minnesota, 55414

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Columbia University

    New York, New York, 10032

  • University of Pennsylvannia

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Washington University

    St Louis, Missouri, 63110

  • Baylor Scott and White

    Temple, Texas, 76502

Other trials in United States

About this study

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

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

Read the 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]).

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02424227
Study groupRoleWhat they receive
Kidney Transplant RecipientsAdult living and deceased donor kidney transplant recipients will be eligible to participate in this study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical T cell as well as antibody mediated acute rejection

    Measured: Occurring within 12 months post transplant

  2. Sub-clinical T cell as well as antibody mediated acute rejection

    Measured: Occurring within 12 months post transplant

  3. Composite of clinical and sub-clinical T cell as well as antibody mediated acute rejection

    Measured: Occurring within 12 months post transplant

Secondary outcomes (2)

  1. 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

    Measured: 24 months

  2. Renal allograft injury from BKV nephritis, CNI toxicity, acute pyeloenephrtiis and recurrent disease confirmed by renal histology

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completion30 Aug 2018
  4. Study completion31 Jan 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
401 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02424227
Sponsor's protocol ID
SN-C-00006
Acronym
DART
Status last verified
Dec 2018
First submitted
20 Apr 2015
Last updated
17 Dec 2018
Results posted
No
Data monitoring committee
No

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.

    PubMed 24472190

  • Lo YM. Transplantation monitoring by plasma DNA sequencing. Clin Chem. 2011 Jul;57(7):941-2. doi: 10.1373/clinchem.2011.166686. No abstract available.

    PubMed 21566070

  • 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.

    PubMed 21444804

  • 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. No abstract available.

    PubMed 24140666

  • 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.

    PubMed 23756769

  • 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.

    PubMed 24944192

  • Sawinski DL, Mehta S, Alhamad T, Bromberg JS, Fischbach B, Aeschbacher T, Ghosh S, Shekhtman G, Dholakia S, Brennan DC, Poggio E, Bloom RD, Jordan SC. Association between dd-cfDNA levels, de novo donor specific antibodies, and eGFR decline: An analysis of the DART cohort. Clin Transplant. 2021 Sep;35(9):e14402. doi: 10.1111/ctr.14402. Epub 2021 Jul 14.

    PubMed 34184326

  • Bromberg JS, Brennan DC, Poggio E, Bunnapradist S, Langone A, Sood P, Matas AJ, Mannon RB, Mehta S, Sharfuddin A, Fischbach B, Narayanan M, Jordan SC, Cohen DJ, Zaky ZS, Hiller D, Woodward RN, Grskovic M, Sninsky JJ, Yee JP, Bloom RD. Biological Variation of Donor-Derived Cell-Free DNA in Renal Transplant Recipients: Clinical Implications. J Appl Lab Med. 2017 Nov 1;2(3):309-321. doi: 10.1373/jalm.2016.022731.

    PubMed 33636851

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplant Recipients, run by CareDx at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical T cell as well as antibody mediated acute rejection (time frame: Occurring within 12 months post transplant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02424227, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.

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