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ISRCTN
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ISRCTN17970029
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ClinicalTrials.gov identifier
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Public title
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Randomised trial to compare the clinical value of cyclosporin C12 and C2 monitoring after lung transplantation
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Scientific title
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Acronym
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N/A
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Serial number at source
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P00784
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Study hypothesis
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Does improved control of the variability in exposure to cyclosporin by monitoring C2 in lung transplant recipients help to reduce the propensity of these patients to cyclosporin-associated side effects whilst maintaining effective immunosupression?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Lung transplant recipients
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Participants - inclusion criteria
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90 patients lung transplant:
1. Adult single or double lung and heart + lung transplant recipients (18 years and older)
2. Patients receiving Neoral as primary immunosuppression
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Participants - exclusion criteria
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1. Patients not giving voluntary, written informed consent to participate
2. Re-transplantation
3. Simultaneous kidney, pancreas, liver or bowel transplantation
3. Urine output <50 ml/hour and/or serum creatinine ≥170 mmol/l at the most recent investigation prior to transplantation
4. Renal replacement therapy or any form of renal support such as continuous veno-venous haemofiltration (CVVH) or dialysis before transplantation or within the first post-operative week
5. Patients receiving tacrolimus or sirolimus as primary immuno-suppression in place of Neoral
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Anticipated start date
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01/04/2003
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Anticipated end date
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01/04/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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90
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Interventions
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Patients will be randomised into 3 groups to compare the clinical value of both 'high' and 'low' C2 monitoring strategies with conventional C12 monitoring as a guide to cyclosporin Neoral dosage adjustment after lung transplantation.
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Primary outcome measure(s)
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Renal function at 3 months post transplant
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Novartis Pharmaceuticals (UK)
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Trial website
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Publications
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1. Cornelissen J, Wood A, Sivasothy P, Trull A, Wallwork J. Randomised trial of cyclosporin C0 vs. C2 monitoring in de novo lung transplant recipients: Interim results. Presented at the 25th International Society of Heart and Lung Transplantation, Philadelphia. J Heart Lung Transplantation 2005;24(2S):S81.
2. Cornelissen J, Trull AK, Parameshwar J, Bellm S, Charman S, Wallwork J. Difficulty in managing cyclosporin C2 monitoring in de novo lung transplant recipients. Presented at the 24th International Society of Heart and Lung Transplantation, San Francisco. J Heart Lung Transplantation 2004;23(2S):S139.
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Contact name
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Dr
Pasupathy
Sivasothy
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Address
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Transplant Unit
Papworth Hospital NHS Trust
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City/town
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Papworth Everard
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Zip/Postcode
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CB3 8RE
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Country
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United Kingdom
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Sponsor
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Papworth Hospital NHS Trust (UK)
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Address
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Papworth Everard
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City/town
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Cambridge
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Zip/Postcode
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CB3 8RE
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Country
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United Kingdom
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Date applied
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16/05/2005
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Last edited
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16/09/2009
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Date ISRCTN assigned
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08/07/2005
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