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

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ClinicalTrials.gov Identifier: NCT02424227
Recruitment Status : Unknown
Verified December 2018 by CareDx.
Recruitment status was:  Active, not recruiting
First Posted : April 22, 2015
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
CareDx

Tracking Information
First Submitted Date April 20, 2015
First Posted Date April 22, 2015
Last Update Posted Date December 17, 2018
Study Start Date April 2015
Actual Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 21, 2015)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 21, 2015)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation
Official Title Circulating Donor-Derived Cell-free DNA in Blood for Diagnosing Acute Rejection in Kidney Transplant Recipients
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
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
cfDNA samples collected in Cell-Free DNA BCT and mRNA collected in PAX gene tubes will be retained
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.
Condition Kidney Transplant Recipients
Intervention Not Provided
Study Groups/Cohorts Kidney Transplant Recipients
Adult living and deceased donor kidney transplant recipients will be eligible to participate in this study.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: June 13, 2016)
401
Original Estimated Enrollment
 (submitted: April 21, 2015)
200
Estimated Study Completion Date January 31, 2019
Actual Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02424227
Other Study ID Numbers SN-C-00006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party CareDx
Study Sponsor CareDx
Collaborators Not Provided
Investigators
Study Director: James Yee, MD CareDx
PRS Account CareDx
Verification Date December 2018