Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/19/2018 |
Start Date: | April 2015 |
End Date: | January 31, 2019 |
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
blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn
after transplant
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]).
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]).
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
We found this trial at
14
sites
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Arthur Matas, MD
Phone: 612-625-2469
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Principal Investigator: Shikha Mehta, MD
Phone: 205-996-7733
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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425 University Blvd.
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Asif Sharfuddin, MD
Phone: 317-944-7580
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Stanley Jordan, MD
Phone: 310-423-1518
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Anthony Langone, MD
Phone: 615-936-1184
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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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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2049 E 100th St
Cleveland, Ohio 44106
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Emilio Poggio, MD
Phone: 216-444-4650
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Fort Worth, Texas 76104
Principal Investigator: Bernard Fischbach
Phone: 817-922-2586
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Philadelphia, Pennsylvania 19104
Principal Investigator: Roy Bloom, MD
Phone: 215-615-0773
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Principal Investigator: Puneet Sood
Phone: 412-864-3781
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Temple, Texas 76504
Principal Investigator: Mohanram Narayanan, MD
Phone: 254-935-5838
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