The use of the drug everolimus to reduce hypertrophy of the hearts left ventricle in kidney transplant recipients

ISRCTN	ISRCTN93681079
DOI	https://doi.org/10.1186/ISRCTN93681079
Secondary identifying numbers	n/a

Submission date: 16/03/2011
Registration date: 08/04/2011
Last edited: 08/04/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Giuseppe Cannella
Scientific

Largo R.Benzi 10
Genova
16132
Italy

Study information

Study design	Open-label randomised trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effect of the mammalian Target Of Rapamycin (mTOR) inhibitor everolimus on reducing left ventricular hypertrophy in renal transplant recipients (RTRs)
Study objectives	To investigate if mTOR everolimus induces regression of left ventricular hypertrophy (LVH) of renal transplant recipients (RTRs).
Ethics approval(s)	Ethics approval was not required as the trial complies with the recommendations issued by the ethical committee of the San Martino University Hospital (Azienda Ospedaliera Universitaria), Genoa, Italy.
Health condition(s) or problem(s) studied	Non diabetic patients receiving kidney transplants
Intervention	1. Randomisation to either everolimus (EVL) plus reduced-exposure cyclosporine A (CsA) or standard-dose CsA 2. Anti-interleukin-2 receptor monoclonal antibodies for induction and steroids in both groups 3. Mycophenolate mofetil allowed in standard-dose CsA group 4. Antihypertensive therapy not including renin-angiotensin blocking agents allowed to achieve blood pressure (BP) of nearly 130/80 mmHg
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	mTOR everolimus
Primary outcome measure	Change in left ventricular mass index which is assessed by echocardiography after 1 year
Secondary outcome measures	1. Changes in renal graft function at one and three years 2. Incidence of acute rejection episodes at one and three years
Overall study start date	01/01/2008
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	30
Key inclusion criteria	Non diabetic renal transplant recipients (RTRs)
Key exclusion criteria	1. Patients receiving second transplant 2. Patients receiving dual transplant 3. Diabetic patients 4. Patients with severe cardiac valvular abnormalities
Date of first enrolment	01/01/2008
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Italy

Study participating centre

Largo R.Benzi 10

Genova
16132
Italy

Sponsor information

San Martino University Hospital (Azienda Ospedaliera Universitaria San Martino) (Italy)
Hospital/treatment centre

Largo R.Benzi
c/o Prof. Giuseppe Cannella
Genova
16132
Italy

"ROR"	https://ror.org/04d7es448

Funders

Funder type

Government

The Italian National Health Service (Servizio Sanitario Nazionale) (Italy)

No information available

San Martino University Hospital (Azienda Ospedaliera Universitaria San Martino), Genoa (Italy)