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

mRNA and microRNA Profiles in Renal Transplant at the Time of Organ Reperfusion

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 Overview

• Status: Suspended
• Conditions: Kidney Transplantation
• Intervention / Treatment: Procedure: Kidney Biopsy

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Meredith J Aull, PharmD; Phone Number: (212) 746-5330; Email: mea9008@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Renal allograft recipients are generally in good health and many return to work by three months post-transplant.

However, they are maintained on immunosuppressive medications to maintain the function of the transplanted kidney.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of early organ dysfunction, defined by standard criteria for each organ defined as the need for dialysis within 7 days after transplant and incidence of biopsy proven acute cellular rejection within 12 months of transplant	7 days and 12 months, respectively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Creatinine	Correlation between proinflammatory mediators at the time of transplantation and renal function as measured by serum creatinine	24 months
Incidence of chronic allograft nephropathy	Correlation between proinflammatory mediators at the time of transplantation and incidence of chronic allograft nephropathy	24 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Qatar National Research Fund
• Investigators: Principal Investigator: Thangamani Muthukumar, MD, Weill Cornell Medicine/Department of Surgery

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2010
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: January 5, 2011
• First Submitted That Met QC Criteria: January 5, 2011
• First Posted (Estimated): January 6, 2011

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1004010988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED