Analysis of Donor Biopsy Tissue Samples at the Time of Kidney Transplant
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/17/2018 |
| Start Date: | September 2010 |
| End Date: | December 2025 |
| Contact: | Sandip Kapur, MD |
| Email: | sak2009@med.cornell.edu |
| Phone: | (212) 746-5330 |
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.
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.
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.
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.
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
We found this trial at
1
site
New York, New York 10021
Principal Investigator: Sandip Kapur, MD
Phone: 212-746-5330
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