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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01271465
• Other study ID #: 1004010988
• Status: Suspended
• Start date: September 2010
• Est. completion date: December 2031

Study information

• Verified date: January 2024
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 120
• Est. completion date: December 2031
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Procedure:
• Kidney Biopsy
biopsy of transplant kidney

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Qatar National Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		7 days and 12 months, respectively
Secondary	Serum Creatinine	Correlation between proinflammatory mediators at the time of transplantation and renal function as measured by serum creatinine	24 months
Secondary	Incidence of chronic allograft nephropathy	Correlation between proinflammatory mediators at the time of transplantation and incidence of chronic allograft nephropathy	24 months