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

NCT ID: NCT01271465

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2031-12-31

Brief Summary

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.

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.

Conditions

Kidney Transplantation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Kidney Biopsy

biopsy of transplant kidney

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qatar National Research Fund

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thangamani Muthukumar, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell Medicine/Department of Surgery

Locations

Weill Cornell Medical College

New York, New York, United States

Countries

United States

Other Identifiers

1004010988

Identifier Type: -

Identifier Source: org_study_id