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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Weill Medical College of Cornell University
Information provided by (Responsible Party):
Weill Medical College of Cornell University Identifier:
First received: January 5, 2011
Last updated: March 1, 2017
Last verified: March 2017
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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:
  • 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 Outcome Measures:
  • Serum Creatinine [ Time Frame: 24 months ]
    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 ]
    Correlation between proinflammatory mediators at the time of transplantation and incidence of chronic allograft nephropathy

Biospecimen Retention:   Samples With DNA
Blood, urine, and kidney tissue will be analyzed for mRNA and microRNA expression of pro-inflammatory genes.

Estimated Enrollment: 120
Actual Study Start Date: September 2010
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Kidney Biopsy
    biopsy of transplant kidney
Detailed Description:


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.


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.


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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.


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 identifier: NCT01271465

Contact: Jim Kim, MD (212) 746-5330

United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Jim Kim, MD    212-746-5330   
Principal Investigator: Jim Kim, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
  More Information

Responsible Party: Weill Medical College of Cornell University Identifier: NCT01271465     History of Changes
Other Study ID Numbers: 1004010988
Study First Received: January 5, 2011
Last Updated: March 1, 2017
Individual Participant Data  
Plan to Share IPD: Undecided processed this record on May 23, 2017