NCT02514733

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

1.9 years

First QC Date

July 28, 2015

Last Update Submit

September 21, 2018

Conditions

Complication of Transplant

Keywords

kidneytransplant

Outcome Measures

Primary Outcomes (1)

  • Graft failure

    Graft failure in this study is defined as need for chronic dialysis or re-transplant.

    2 years post transplant

Secondary Outcomes (1)

  • Recipient survival

    2 years post transplant

Study Arms (2)

Young donor

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

Old donor

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

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All older kidney transplant recipients, age \>=60 at transplant who underwent the procedure at Northwestern University during specified time frame ( see below)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Comprehensive Transplant Center

Chicago, Illinois, 60611, United States

Location

Related 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.

    PMID: 23261121BACKGROUND

Study Officials

  • Lorenzo Gallon, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Medicine-Nephrology and Surgery-Organ Transplantation

Study Record Dates

First Submitted

July 28, 2015

First Posted

August 4, 2015

Study Start

May 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

September 25, 2018

Record last verified: 2018-09

Locations

US(1)