New York, New York 10065

  • Kidney Transplantation

Purpose:

The purpose of this study is to see if substances measured in a small piece of the donor organ predicts how well the organ will function in the recipient after transplant. We will be testing blood, urine, and biopsy tissue samples in this study. The research team will be looking at different risk factors in the donor organ that predict how well the kidney will do in the recipient.


Study summary:

Background: Early post-transplant kidney function can be attributed to inherent donor characteristics, damage from storage, and perioperative events and recipients factors. The incidence of severe injury to the transplant kidneys is 10-25% in the early post-transplant period. In addition, milder forms of early transplant kidney injury can impact on long term allograft function. Severe transplant kidney injury in the immediate post-transplant period has been hypothesized to be associated with higher rates of rejection. Hypothesis: In the current investigation, we would like to test the hypotheses that 1) mRNA and microRNA expression of proinflammatory genes in donor tissues is a risk factor for development of early kidney transplant dysfunction and 2) early inflammatory mRNA and microRNA expression in the allograft is associated with subsequent activation of cell mediated immunity as evidenced by increased incidence of acute rejection episodes and increased expression of cell mediated immunity genes during the first year post-transplant. Aims: Aim 1: Test the association between proinflammatory mRNA and microRNA expression in donor samples and subsequent development of early organ dysfunction in the immediate period following transplantation. Aim 2: Test the association of mRNA and microRNA expression of proinflammatory mediators in the transplanted organ in the immediate pre and post-reperfusion period with subsequent incidence of acute rejection and expression of genes involved in cell mediated immunity.


Criteria:

Inclusion Criteria: - Males and females <80 years of age for kidney - Recipients of single abdominal organ transplant - Ability to provide written informed consent - Donor blood and kidney biopsy tissues specimens are collected at the time of transplantation Exclusion Criteria: - Need for combined organ transplantation. - Inability or unwillingness of a participant or legal guardian to provide written informed consent - Clinical evidence of systemic bacterial infection in the recipient at the time of transplantation


NCT ID:

NCT01271465


Primary Contact:

Principal Investigator
Samuel Sultan, MD
Weill Cornell Medicine/Department of Surgery

Meredith J Aull, PharmD
Phone: (212) 746-5330
Email: mea9008@med.cornell.edu


Backup Contact:

N/A


Location Contact:

New York, New York 10065
United States

Meredith J Aull, PharmD
Phone: 212-746-5330
Email: mea9008@med.cornell.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 08, 2022

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