Association of Donor Age With Recipient Outcomes in Kidney Transplant

Complication of Transplant Clinical Trial

Official title:

Association of Donor Age With Recipient Outcomes in Kidney Transplant

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02514733
• Other study ID #: STU00200153
• Status: Terminated
• Start date: May 2016
• Est. completion date: April 2018

Study information

• Verified date: September 2018
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Exclusion Criteria:

• Recipients of more than one kidney transplant

• Recipients of multi-organ transplants

Related Conditions & MeSH terms

• Complication of Transplant

Locations

Country	Name	City	State
United States	Northwestern University Comprehensive Transplant Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Knoll GA. Kidney transplantation in the older adult. Am J Kidney Dis. 2013 May;61(5):790-7. doi: 10.1053/j.ajkd.2012.08.049. Epub 2012 Dec 20. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft failure	Graft failure in this study is defined as need for chronic dialysis or re-transplant.	2 years post transplant
Secondary	Recipient survival		2 years post transplant