Association of Donor Age With Recipient Outcomes in Kidney Transplant

Terminated

• Conditions: Complication of Transplant

• Registration Number: NCT02514733
• Lead Sponsor: Northwestern University

Brief Summary

This is a single center study that seeks to study the impact of donor age on recipient outcomes in older kidney transplant recipients.

Detailed Description

Over the years use of older kidney allografts has increased in an attempt to bridge the gap between demand and supply of organs. Simultaneously there has been in increase in the number of elderly renal transplant recipients. Numerous factors, both graft and host related, can impact recipient outcomes. The aim of this study is to evaluate the impact of donor age on recipient outcomes, based on the hypothesis is that elderly recipients who receive an older allograft have poorer outcomes that those who receive a younger allograft.

Study subjects will be recruited from the cohort of patients who received a kidney transplant at Northwestern Memorial Hospital.

The transplant clinical database and electronic medical record (OTTR) used in the Comprehensive Transplant Center at Northwestern University will be scanned to screen for kidney transplant recipients who fit the inclusion and exclusion criteria. Potential subjects will then be consented to participate in the study (see attached consent form), and subject participation will be documented in OTTR.

The sample size for the study is 80 subjects, who will be divided into 2 groups based on recipient and donor age. All demographic and clinical data will be collected for the donor and recipients at time of transplant. Follow up clinical data, including but not limited to recipient survival and graft failure will be collected and analyzed for the recipients. Subject confidentiality will be strictly maintained. All subject data will be stored on a secure server and only shared between members of the research team. The investigators plan to publish the results in a peer reviewed journal.

Study Timeline

• Study First Submitted: 2015-07-28
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-08-04
• Study Start: 2016-05
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• All adult kidney transplant recipients
• Recipient age > 60 years at the time of transplant
• Transplant was done between January 1, 2013 and December 31, 2014

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Exclusion Criteria

• Recipients of more than one kidney transplant
• Recipients of multi-organ transplants

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Graft failure	2 years post transplant	Graft failure in this study is defined as need for chronic dialysis or re-transplant.

Secondary Outcome Measures

Name	Time	Method
Recipient survival	2 years post transplant

Trial Locations

Locations (1)

Northwestern University Comprehensive Transplant Center; 🇺🇸 Chicago, Illinois, United States