Deceased Donor Biomarkers and Recipient Outcomes (DDS)
|ClinicalTrials.gov Identifier: NCT01848249|
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : April 9, 2020
|Condition or disease|
|Deceased Donor Kidney Transplant Acute Kidney Injury Delayed Graft Function End Stage Renal Disease Graft Failure|
Our study has several key processes that we have developed and tested to address our scientific aims:
We will collect urine samples from approximately 1600 deceased donors and approximately 600 perfusate samples from machine-pumped kidneys from participating organ procurement organizations (OPOs). We estimate that our final donor group will be comprised of 55% standard criteria donors, 25% expanded-criteria donors and 10% donors after cardiac death. Approximately, 20% of the kidneys will be discarded.
Donor variables come from two sources: the United Network for Organ Sharing (UNOS) database and detailed data abstraction from each OPO. The UNOS database provides data on all donors with demographics and other important clinical characteristics. The additional data collected by the OPO staff captures granular information on events surrounding donor death, which are not included in the UNOS database. These data will be available on all enrolled donors and include variables such as serial serum creatinine, nadir blood pressures, medication and vasopressor use, and machine pump parameters.
Overall Recipient Cohort
Over 2000 recipients will have received kidneys from the deceased donors in our study. The Overall Cohort will comprise all of these recipients General demographic and clinical characteristics about recipients in the Overall Cohort will come from the UNOS database. For the Overall Recipient Cohort, we will ascertain delayed graft function (DGF) through center reports to UNOS. We will ascertain allograft failure through center reports to UNOS and new episodes of wait-listing and re-transplant collected by UNOS, Recipient mortality will be ascertained through the center reports to UNOS/SRTR and through the Social Security Death Master File.
Detailed Recipient Cohort
A subset of over 1100 recipients of the Overall Cohort who had transplantation at any of our collaborating transplant centers will comprise this cohort. For the Detailed Subcohort, on-site coordinators will perform manual chart review and abstract more extensive data about each recipient including dialysis indications post-transplant, comorbidities, and specific doses of immunosuppression. For the Detailed Subcohort, we will also collect data on clinical events for up to five years after transplantation, including acute rejection and estimated glomerular filtration rate at the time of transplantation and at months 1, 3, 6, 12, 18, 24, 30, 36, 48 and 60 months after transplant.
- Novel biomarkers will be measured in urine and perfusate
|Study Type :||Observational|
|Actual Enrollment :||1679 participants|
|Official Title:||Deceased Donor Urinary Biomarkers to Predict Kidney Transplant Outcomes|
|Study Start Date :||May 1, 2010|
|Actual Primary Completion Date :||December 2019|
|Actual Study Completion Date :||March 2020|
We will collect urine samples from approximately 1600 deceased donors and approximately 600 perfusate samples from machine-pumped kidneys from participating organ procurement organizations (OPOs).
Recipient Cohort (Overall and Detailed)
No samples will be collected from the recipients. Only clinical data and outcomes will be collected from the recipients.
- Delayed Graft Function [ Time Frame: Assessed within first week of receiving renal transplant ]Receipt of dialysis within the first seven days post renal transplant
- Death-Censored Graft Failure (Overall Cohort) [ Time Frame: median of 4 years of follow-up ]Requirement of chronic dialysis or retransplantation after renal transplant.
- Graft Function (detailed cohort) [ Time Frame: median of 4 years of follow-up ]Serum creatinine and estimated glomerular filtration rate at specified time points over a five year period.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848249
|Principal Investigator:||Chirag R Parikh, MD PhD||Yale University|