Skip to main content
OpenTrials
Completed

NCT Number: NCT01271465

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Transplantation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Weill Cornell Medical College

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kidney Biopsy

Procedure

biopsy of transplant kidney

Primary outcomes

  1. 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

    Time frame: 7 days and 12 months, respectively

Secondary outcomes

  1. Serum Creatinine

    Time frame: 24 months

    Correlation between proinflammatory mediators at the time of transplantation and renal function as measured by serum creatinine

  2. Incidence of chronic allograft nephropathy

    Time frame: 24 months

    Correlation between proinflammatory mediators at the time of transplantation and incidence of chronic allograft nephropathy

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Qatar National Research Fund

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2011
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.