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ISRCTN
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ISRCTN54216890
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ClinicalTrials.gov identifier
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Public title
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Substitution of calcineurin inhibitors with sirolimus on left ventricular hypertrophy (LVH) of renal transplant recipients (RTR)
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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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N/A
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Study hypothesis
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Substitution of calcineurin inhibitors (CNI) with sirolimus may regress left ventricular hypertrophy (LVH) of renal transplant recipients (RTR).
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Ethics approval
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Ethics approval was not required as this trial complies with the recommendations issued by the ethical committee of the San Martino University Hospital (Azienda Ospedaliera Universitaria San Martino).
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Study design
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Non-randomised controlled trial.
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Chronic allograft nephropathy in renal transplant recipients; left ventricular hypertrophy
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Participants - inclusion criteria
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1. Age 25-66 years, both males and females
2. Non diabetic RTR with biopsy-proven chronic allograft nephropathy
3. Patients who have received a single kidney in 2004
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Participants - exclusion criteria
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1. Diabetic RTR
2. Patients receiving kidney transplant from living donors
3. Patients receiving dual kidney allograft
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Anticipated start date
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01/06/2004
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Anticipated end date
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31/01/2006
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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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42
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Interventions
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28 men and 14 women (total of 42 patients) were enrolled in this study.
All patients started CNI therapy. Subjects with chronic allograft nephropathy were switched to sirolimus, whereas patients not having chronic allograft nephropathy continued CNI and served as controls (non-randomised trial). The dose of sirolimus was titrated every other week in order to maintain trough levels between 5 and 15 mg/ml.
Duration of interventions: Interventions will continue as long as the participants require these immunosuppressants.
Total duration of follow-up: 12 months
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Primary outcome measure(s)
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Changes in left ventricular mass (LVMi) at 12 months
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Secondary outcome measure(s)
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Changes in serum creatinine as a measure of graft function at 12 months
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Sources of funding
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1. The Italian National Health Service (Servizio Sanitario Nazionale [SSN]) (Italy)
2. San Martino University Hospital (Azienda Ospedaliera Universitaria San Martino) (Italy)
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Trial website
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Publications
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Contact name
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Dr
Giuseppe
Cannella
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Address
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L.go R.Benzi 10
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City/town
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Genova
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Zip/Postcode
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16132
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Country
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Italy
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Sponsor
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San Martino University Hospital (Azienda Ospedaliera Universitaria San Martino) (Italy)
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Address
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c/o Dr Giuseppe Cannella
L. go R. Benzi 10
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City/town
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Genova
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Zip/Postcode
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16132
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Country
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Italy
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Date applied
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28/04/2008
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Last edited
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21/05/2008
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Date ISRCTN assigned
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12/05/2008
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