Kidney Allograft Recipients in England - an Observational Cohort Study (KARE)

February 21, 2013 updated by: Adnan Sharif, University Hospital Birmingham NHS Foundation Trust

An Observation Cohort Study of Kidney Allograft Recipients in England by Data Linkage Analysis

Kidney transplantation is the renal replacement therapy of choice for the majority of patients with end-stage kidney disease. Epidemiological studies of kidney allograft recipients can aid in the understanding of cause and effect of health and disease post-transplantation. The combination of health care and information technology has made the potential of transplant professionals to use health information effectively crucial to guide kidney transplant management. The aim of this study is to undertake an observational cohort study of kidney allograft recipients, supported by linking analysis across different database sources, to provide a comprehensive biomedical dataset of information.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

19688

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2WB
        • University Hospitals Birmingham NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All kidney allograft recipients transplanted at an English transplant centre between April 2001 and March 2012

Description

Inclusion Criteria:

  • Kidney transplant alone
  • English Transplant centre
  • All ages
  • Kidney allograft receipt between April 2001 and March 2012

Exclusion Criteria:

  • Multiple organ transplant
  • Transplant performed at non-English centre

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Kidney allograft recipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality within the first year post kidney transplantation
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality beyond the first year post kidney transplantation
Time Frame: Up to 12 years
Up to 12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 21, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 26, 2013

Study Record Updates

Last Update Posted (Estimate)

February 26, 2013

Last Update Submitted That Met QC Criteria

February 21, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HES-ONS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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