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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
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]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kidney Transplant Recipients | Adult living and deceased donor kidney transplant recipients will be eligible to participate in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical T cell as well as antibody mediated acute rejection | Occurring within 12 months post transplant | |
| Sub-clinical T cell as well as antibody mediated acute rejection | Occurring within 12 months post transplant | |
| Composite of clinical and sub-clinical T cell as well as antibody mediated acute rejection | Occurring within 12 months post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months | |
| Renal allograft injury from BKV nephritis, CNI toxicity, acute pyeloenephrtiis and recurrent disease confirmed by renal histology |
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Inclusion Criteria
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
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Adult de novo living and deceased donor kidney transplant recipients will be eligible to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| James Yee, MD | CareDx | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of California Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24472190 | Background | 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. | |
| 21566070 |
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cfDNA samples collected in Cell-Free DNA BCT and mRNA collected in PAX gene tubes will be retained
| 24 months |
| Los Angeles |
| California |
| 90024 |
| United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvannia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Baylor Research Institute | Fort Worth | Texas | 76104 | United States |
| Baylor Scott and White | Temple | Texas | 76502 | United States |
| Background |
| 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. |
| 21444804 | Background | 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. |
| Background | Code of Federal Regulations, Title 42 - Public Health, Part 493 - Laboratory Requirements, Subpart A - General Provisions, Sections 1, 2 & 3 |
| 24140666 | Background | 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. |
| 23756769 | Background | 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. |
| 24944192 | Background | 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. |
| 34184326 | Derived | 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. |
| 33636851 | Derived | 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. |