Condition category
Surgery
Date applied
16/03/2011
Date assigned
08/04/2011
Last edited
08/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Giuseppe Cannella

ORCID ID

Contact details

Largo R.Benzi 10
Genova
16132
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

n/a

Study information

Scientific title

The effect of the mammalian Target Of Rapamycin (mTOR) inhibitor everolimus on reducing left ventricular hypertrophy in renal transplant recipients (RTRs)

Acronym

Study hypothesis

To investigate if mTOR everolimus induces regression of left ventricular hypertrophy (LVH) of renal transplant recipients (RTRs).

Ethics approval

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.

Study design

Open-label randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

mTOR everolimus

Primary outcome measures

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 trial start date

01/01/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Non diabetic renal transplant recipients (RTRs)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Patients receiving second transplant
2. Patients receiving dual transplant
3. Diabetic patients
4. Patients with severe cardiac valvular abnormalities

Recruitment start date

01/01/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Italy

Trial participating centre

Largo R.Benzi 10
Genova
16132
Italy

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes