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NCT01798524 Clinical Trial

Kidney Allograft Recipients in England - an Observational Cohort Study

Kidney Transplantation Clinical Trial

— KARE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01798524
Other study ID # HES-ONS
Secondary ID
Status Completed
Phase N/A
First received February 21, 2013
Last updated February 21, 2013
Start date November 2011

Study information
Verified date February 2013
Source University Hospital Birmingham NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 19688
Est. completion date
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom University Hospitals Birmingham NHS Foundation trust Birmingham

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Birmingham NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality within the first year post kidney transplantation One year No
Secondary Mortality beyond the first year post kidney transplantation Up to 12 years No
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