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 |
| Protocol serial number | n/a |
| Sponsor | San Martino University Hospital (Azienda Ospedaliera Universitaria San Martino) (Italy) |
| Funders | The Italian National Health Service (Servizio Sanitario Nazionale) (Italy), San Martino University Hospital (Azienda Ospedaliera Universitaria San Martino), Genoa (Italy) |
- 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
Scientific
Largo R.Benzi 10
Genova
16132
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-label randomised trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | mTOR everolimus |
| Primary outcome measure(s) |
Change in left ventricular mass index which is assessed by echocardiography after 1 year |
| Key secondary outcome measure(s) |
1. Changes in renal graft function at one and three years |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
16132
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
