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

NCT01271465 | Completed

• 1 other identifier: 1004010988
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Serum Creatinine

  24 months

• Incidence of chronic allograft nephropathy

  24 months

Interventions

Kidney Biopsy PROCEDURE

biopsy of transplant kidney

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Qatar National Research Fund: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, and kidney tissue will be analyzed for mRNA and microRNA expression of pro-inflammatory genes.

Study Officials

• Samuel Sultan, MD

  Weill Cornell Medicine/Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 6, 2011
• Study Start: September 1, 2010
• Primary Completion: September 18, 2021
• Study Completion: September 18, 2021
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)