Analysis of Donor Biopsy Tissue Samples at the Time of Kidney Transplant

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2011 by Weill Medical College of Cornell University
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01271465
First received: January 5, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  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.


Condition Intervention
Kidney Transplantation
Procedure: Kidney Biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: mRNA and microRNA Profiles in Renal Transplant at the Time of Organ Reperfusion

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Primary endpoint for Aim 1 is the incidence of early organ dysfunction, defined by standard criteria for each organ defined as the need for dialysis within 7 days after transplant [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Primary endpoint for Aim 2 is the incidence of biopsy proven acute cellular rejection within the first 12 months after transplant [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum Creatinine [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Correlation between proinflammatory mediators at the time of transplantation and renal function as measured by serum creatinine

  • Incidence of chronic allograft nephropathy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Correlation between proinflammatory mediators at the time of transplantation and incidence of chronic allograft nephropathy


Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Kidney Biopsy
    biopsy of transplant kidney
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271465

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: David B Leeser, MD    212-746-5330    dbl9004@med.cornell.edu   
Principal Investigator: David B Leeser, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: David B. Leeser, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT01271465     History of Changes
Other Study ID Numbers: 1004010988
Study First Received: January 5, 2011
Last Updated: January 5, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014