Clinical trial NCT01271465: Analysis of Donor Biopsy Tissue Samples at the Time of Kidney Transplant
Official title: mRNA and microRNA Profiles in Renal Transplant at the Time of Organ Reperfusion
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Kidney Transplantation
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Qatar National Research Fund
First posted: 2011-01-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: 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
timeFrame: 7 days and 12 months, respectively
Secondary outcomes:
measure: Serum Creatinine
timeFrame: 24 months
measure: Incidence of chronic allograft nephropathy
timeFrame: 24 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Cornell Medicine/Department of Surgery
name: Thangamani Muthukumar, MD
role: PRINCIPAL_INVESTIGATOR
References: