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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01423552
Registration number
NCT01423552
Ethics application status
Date submitted
23/08/2011
Date registered
26/08/2011
Date last updated
26/08/2011
Titles & IDs
Public title
Pharmacology of Immunosuppressants Following Heart Transplantation
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Scientific title
Correlation of Immunosuppressant Pharmacokinetics, Pharmacodynamics, Pharmacogenomics and Outcomes Following Heart Transplantation
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Secondary ID [1]
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RRK4220
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Transplantation
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Post-heart transplant - All patients undergoing heart transplantation at the Queen Elizabeth Hosptial Birmingham in the last 12 months or in the next year.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Correlation of immunosuppressant drug levels in different compartments with evidence of rejection
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Assessment method [1]
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We will compare the levels of the drugs in different compartments of the body (in the blood, within white blood cells and within the heart muscle itself) with how well the drugs are working ie. how well the heart is functioning and the level of rejection seen on routine heart biopsies. Drug levels will be measured at C0 (trough) and C2 (peak).
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Timepoint [1]
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Multiple timepoints in first 12 months after transplantation
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Secondary outcome [1]
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Correlation of individual patient genetic and other factors with levels of immunosuppressant drugs in different compartments
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Assessment method [1]
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We will also compare these results with patient genetic and other factors (eg. age, kidney function, use of other drugs) to better understand how these factors affect the levels of the drugs in different compartments of the body. Drug levels will be measured at C0 (trough) and C2 (peak).
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Timepoint [1]
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Multiple timepoints in first 12 months after transplantation
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Eligibility
Key inclusion criteria
* All patients undergoing heart transplantation
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Decline participation
* Previous transplantation of another organ and already receiving chronic immunosuppressive therapy
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Basil Hetzel Institute for Medical Research - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment outside Australia
Country [1]
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United Kingdom
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State/province [1]
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West Midlands
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Funding & Sponsors
Primary sponsor type
Other
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Name
Nigel E. Drury
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The ongoing success of transplantation is largely due to the development of drugs to stop the patient's body from rejecting the new organ. In addition to steroids, two main types of drug are used to suppress the immune system following heart transplantation: calcineurin inhibitors (Ciclosporin-A or Tacrolimus) and mycophenolate. However, different patients respond in different ways to these drugs, with the same dose leading to different levels of the drug in the blood. This varies due to genetic and other factors such as age, kidney function and the use of other drugs. Therefore, the levels of immunosuppressive drugs in the blood are routinely measured and the dose adjusted accordingly. However, some patients still experience episodes of rejection despite apparently acceptable levels. In this study, the investigators will measure levels of the drugs (in the blood, in a type of white blood cell called T-cells and in the heart muscle) and the effectiveness of the drugs on T-cells. The investigators will compare these levels with patient genetic factors and the amount of rejection measured on heart biopsies. This will enable us to better understand how the blood and tissue levels of these drugs change with genetic and other factors in order to optimise immunosuppressive therapy and further improve outcomes from heart transplantation.
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Trial website
https://clinicaltrials.gov/study/NCT01423552
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Robert S Bonser, MD FRCS
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Address
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University Hospital Birmingham
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Nigel E Drury, MRCS
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Address
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Country
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Phone
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01216272890
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01423552
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