Substitution of calcineurin inhibitors with sirolimus on left ventricular hypertrophy (LVH) of renal transplant recipients (RTR)
| ISRCTN | ISRCTN54216890 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54216890 |
| 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 [SSN]) (Italy), San Martino University Hospital (Azienda Ospedaliera Universitaria San Martino) (Italy) |
- Submission date
- 28/04/2008
- Registration date
- 12/05/2008
- Last edited
- 25/02/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Giuseppe Cannella
Scientific
Scientific
L.go R.Benzi 10
Genova
16132
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised controlled trial. |
| Secondary study design | Non randomised controlled trial |
| Scientific title | |
| Study objectives | Substitution of calcineurin inhibitors (CNI) with sirolimus may regress left ventricular hypertrophy (LVH) of renal transplant recipients (RTR). |
| Ethics approval(s) | 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). |
| Health condition(s) or problem(s) studied | Chronic allograft nephropathy in renal transplant recipients; left ventricular hypertrophy |
| Intervention | 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 |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | calcineurin inhibitors, sirolimus |
| Primary outcome measure(s) |
Changes in left ventricular mass (LVMi) at 12 months |
| Key secondary outcome measure(s) |
Changes in serum creatinine as a measure of graft function at 12 months |
| Completion date | 31/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 42 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 1. Diabetic RTR 2. Patients receiving kidney transplant from living donors 3. Patients receiving dual kidney allograft |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 31/01/2006 |
Locations
Countries of recruitment
- Italy
Study participating centre
L.go 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? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2012 | Yes | No |
