Association of Donor Age With Recipient Outcomes in Kidney Transplant

NCT ID: NCT02514733

Last Updated: 2018-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-04-30

Brief Summary

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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

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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.

Conditions

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Complication of Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Young donor

Kidney transplant recipient \> 60 years of age who received organ from donor \<=40 years of age

No interventions assigned to this group

Old donor

Kidney transplant recipient \>= 60 years of age who received organ from donor \>=50 years of age

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Lorenzo Gallon

Professor in Medicine-Nephrology and Surgery-Organ Transplantation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lorenzo Gallon, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Comprehensive Transplant Center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23261121 (View on PubMed)

Other Identifiers

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STU00200153

Identifier Type: -

Identifier Source: org_study_id

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