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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01271465
Enrollment
24
Registered
2011-01-06
Start date
2010-09-30
Completion date
2021-09-18
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

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.

Interventions

PROCEDUREKidney Biopsy

biopsy of transplant kidney

Sponsors

Qatar National Research Fund
CollaboratorOTHER
Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 transplant7 days and 12 months, respectively

Secondary

MeasureTime frameDescription
Serum Creatinine24 monthsCorrelation between proinflammatory mediators at the time of transplantation and renal function as measured by serum creatinine
Incidence of chronic allograft nephropathy24 monthsCorrelation between proinflammatory mediators at the time of transplantation and incidence of chronic allograft nephropathy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026