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Patients undergoing kidney transplantation alone (either de-novo or re-transplant) at a participating hospital are routinely surveyed with interval blood tests as part of standard post-operative care through outpatient consultation. These tests include serum creatinine, blood sugar as well as DSA testing at various intervals. The ability to screen patients to better identify those who may be at risk of developing an adverse event using AlloSure cfDNA is likely to be advantageous, with the potential to improve graft survival and outcomes for transplant patients. The addition of AlloSure to the interventional group will be the focus of this study. Patients will have quarterly AlloSure cfDNA testing (every 3 months) and DSA as part of their post-transplant surveillance for a period of 5 years.Participants will attend outpatient visits/follow-up visits as part of their standard care, these will include appointments where they will have blood tests taken as part of post-transplant surveillance. For AlloSure cfDNA and DSA, blood will be taken quarterly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AlloSure Group | Patients will have quarterly AlloSure cfDNA testing (every 3 months) and DSA as part of their post-transplant surveillance for a period of 5 years. For the quarterly AlloSure tests, approximately 20 mL of blood will be obtained in Streck Cell-Free DNA BCT tubes and shipped to CareDx, Inc. (Brisbane, CA) to analyze the presence of donor-derived cell-free DNA. |
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| Control Group | The control group was never followed with AlloSure as part of their post-transplant follow-up care. Matched control data will originate from UNOS SRTR data. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlloSure | Device | AlloSure is an analytically validated targeted next-generation sequencing (NGS) assay that uses single-nucleotide polymorphisms (SNPs) to measure the fraction of dd-cfDNA in transplant patients without the need for genotyping either the donor or the recipient.8 |
| Measure | Description | Time Frame |
|---|---|---|
| Superior allograft survival | Time to allograft loss, defined as composite of: return to dialysis, re-transplant, death due to allograft failure, and death with functioning allograft. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of kidney function | Relative change in eGFR from baseline in groups monitored using AlloSure compared to matched control group. | 5 years |
| Assessment of immunologic status | Proportion of patients with formation of de-novo DSA antibodies in groups monitored using AlloSure compared to matched control group. |
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Inclusion Criteria:
Exclusion Criteria:
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Kidney transplant patients who are having their transplant follow-up care in community nephrology
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amicis Research Center | Fairfield | California | 94533 | United States | ||
| The Medical Research Group - Fresno |
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AlloSure Kidney is a blood test that analyzes SNPs selected across all 22 somatic chromosomes to detect DNA released from a patient's kidney allograft, known as donor-derived cell-free DNA (dd-cfDNA).
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| 5 years |
| Fresno |
| California |
| 93720 |
| United States |
| Amicis Research Center | Granada Hills | California | 91344 | United States |
| Amicis Research Center | Mission Hills | California | 91345 | United States |
| California Institute of Renal Research (Balboa) | San Diego | California | 92123 | United States |
| Starling Physicians | Hartford | Connecticut | 06106 | United States |
| George Washington/Medical Faculty Associates Inc. | Washington D.C. | District of Columbia | 20037 | United States |
| Physician Consultants of Georgia | Macon | Georgia | 31201 | United States |
| NANI Research | Hinsdale | Illinois | 60521 | United States |
| NANI Research | Fort Wayne | Indiana | 46804 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| PRINE Health | Manhasset | New York | 11030 | United States |
| Chinatown Kidney | New York | New York | 10013 | United States |
| Nephrology Associates PC, Queens | Queens | New York | 11355 | United States |
| Sholer Chris MD | Oklahoma City | Oklahoma | 73116 | United States |
| Utah Kidney Research Institute | South Ogden | Utah | 84403 | United States |
| Lynchburg Nephrology Physicians, PLLC | Lynchburg | Virginia | 24501 | United States |
| Mendez Center for Clinical Research | Woodbridge | Virginia | 22192 | United States |