Kidney TransplantationKARENCT01798524
Kidney Allograft Recipients in England - an Observational Cohort Study
An observational study of Kidney Transplantation, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplantation
- How many people
- 19,688 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All kidney allograft recipients transplanted at an English transplant centre between April 2001 and March 2012
Who may be able to join
- Kidney transplant alone
- English Transplant centre
- All ages
- Kidney allograft receipt between April 2001 and March 2012
Who cannot join
- Multiple organ transplant
- Transplant performed at non-English centre
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Birmingham NHS Foundation trust
Birmingham, B15 2WB
About this study
Official title: 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.
- Conditions
- Kidney Transplantation
- Keywords
- Transplant, Kidney, England
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Kidney allograft recipients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality within the first year post kidney transplantation
Measured: One year
Secondary outcomes (1)
Mortality beyond the first year post kidney transplantation
Measured: Up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startNov 2011
- Primary completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19,688 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Sharif, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798524
- Sponsor's protocol ID
- HES-ONS
- Acronym
- KARE
- Status last verified
- Feb 2013
- First submitted
- 21 Feb 2013
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observation Cohort Study of Kidney Allograft Recipients in England by Data Linkage Analysis
- ClinicalTrials.gov ID
- NCT01798524
- Acronym / sponsor ID
- KARE / HES-ONS
- Conditions
- Kidney Transplantation
- Keywords
- Transplant, Kidney, England
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,688 participants (actual)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2013 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney allograft recipients | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All kidney allograft recipients transplanted at an English transplant centre between April 2001 and March 2012
Key inclusion criteria (4 listed)
- Kidney transplant alone
- English Transplant centre
- All ages
- Kidney allograft receipt between April 2001 and March 2012
Key exclusion criteria (2 listed)
- Multiple organ transplant
- Transplant performed at non-English centre
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality within the first year post kidney transplantation
Time frame: One year
1 secondary outcome
Mortality beyond the first year post kidney transplantation
Time frame: Up to 12 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality within the first year post kidney transplantation (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2013.