Acute Kidney Injury Clinical Trial
— DDSOfficial title:
Deceased Donor Urinary Biomarkers to Predict Kidney Transplant Outcomes
Verified date | April 2020 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Compared to chronic dialysis, kidney transplantation provides recipients with longer survival and better quality of life at a lower cost. In order to meet increasing demands for kidney allografts, kidneys from older and sicker donors are being procured. This has led to greater discard rates of donated kidneys as well as more complications for recipients, including shorter allograft survival. Available clinical models to predict kidney allograft quality have poor prognostic ability and do not asses the degree of kidney allograft injury. However, allograft injury near the time of procurement can lead to major consequences for the transplant recipient: greater risks of delayed graft function, poor allograft function and premature loss of the transplant. Our proposal is based on the hypotheses that novel biomarkers measured in donor urine and transport media at the time of procurement can assess acute and chronic kidney injury and that distinct biomarker patterns will predict allograft survival. In collaboration with five organ procurement organizations, we will collect urine samples from consecutive deceased donors and samples of transport solution for every pumped kidney. We will measure markers of injury, repair, inflammation and fibrosis. We will determine mortality and allograft survival in all patients by linkage to the United Network for Organ Sharing (UNOS) database (Overall Cohort). Additionally, we will perform a detailed chart review of a subset of recipients (detailed cohort) and will also examine associations between biomarkers and longitudinal graft function over five years after transplant. Early, non-invasive and rapid assessment of donor kidney injury could drive better allocation decisions and potentially reduce the rates of post-transplant complications. Further, these new tools could provide a platform for clinical trials of therapies for allografts and kidney transplant recipients aimed at ameliorating allograft injury.
Status | Completed |
Enrollment | 1679 |
Est. completion date | March 2020 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Donor Cohort: Appropriate informed consent for research according to OPO policies - Recipient Cohorts: Any recipient of at least one kidney from a deceased donor enrolled by our participating OPOs Exclusion Criteria: • Donor Cohort: Lack of adequate biospecimen quantity or quality as per protocol |
Country | Name | City | State |
---|---|---|---|
United States | Gift of Life Michigan | Ann Arbor | Michigan |
United States | University of Maryland Medical Center | Baltimore | Maryland |
United States | Harper University Hospital | Detroit | Michigan |
United States | St. Barnabas Medical Center | Livingston | New Jersey |
United States | Yale New Haven Hospital | New Haven | Connecticut |
United States | New Jersey Sharing Network | New Providence | New Jersey |
United States | Montefiore Medical Center | New York | New York |
United States | Mount Sinai School of Medicine | New York | New York |
United States | New York Organ Donor Network | New York | New York |
United States | NewYork-Presbyterian/ Columbia University Irving Medical Center | New York | New York |
United States | The New York Hospital (Cornell) | New York | New York |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | Gift of Life Donor Program- Philadelphia | Philadelphia | Pennsylvania |
United States | Hahnemann University Hospital | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | New England Organ Bank | Waltham | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Yale University | Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Hall IE, Bhangoo RS, Reese PP, Doshi MD, Weng FL, Hong K, Lin H, Han G, Hasz RD, Goldstein MJ, Schröppel B, Parikh CR. Glutathione S-transferase iso-enzymes in perfusate from pumped kidneys are associated with delayed graft function. Am J Transplant. 2014 — View Citation
Hall IE, Reese PP, Weng FL, Schröppel B, Doshi MD, Hasz RD, Reitsma W, Goldstein MJ, Hong K, Parikh CR. Preimplant histologic acute tubular necrosis and allograft outcomes. Clin J Am Soc Nephrol. 2014 Mar;9(3):573-82. doi: 10.2215/CJN.08270813. Epub 2014 — View Citation
Liu C, Hall IE, Mansour S, Thiessen Philbrook HR, Jia Y, Parikh CR. Association of Deceased Donor Acute Kidney Injury With Recipient Graft Survival. JAMA Netw Open. 2020 Jan 3;3(1):e1918634. doi: 10.1001/jamanetworkopen.2019.18634. — View Citation
Puthumana J, Hall IE, Reese PP, Schröppel B, Weng FL, Thiessen-Philbrook H, Doshi MD, Rao V, Lee CG, Elias JA, Cantley LG, Parikh CR. YKL-40 Associates with Renal Recovery in Deceased Donor Kidney Transplantation. J Am Soc Nephrol. 2017 Feb;28(2):661-670. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delayed Graft Function | Receipt of dialysis within the first seven days post renal transplant | Assessed within first week of receiving renal transplant | |
Primary | Death-Censored Graft Failure (Overall Cohort) | Requirement of chronic dialysis or retransplantation after renal transplant. | median of 4 years of follow-up | |
Secondary | Graft Function (detailed cohort) | Serum creatinine and estimated glomerular filtration rate at specified time points over a five year period. | median of 4 years of follow-up |
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