Condition category
Injury, Occupational Diseases, Poisoning
Date applied
28/04/2008
Date assigned
12/05/2008
Last edited
25/02/2013
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

Dr Giuseppe Cannella

ORCID ID

Contact details

L.go R.Benzi 10
Genova
16132
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Substitution of calcineurin inhibitors (CNI) with sirolimus may regress left ventricular hypertrophy (LVH) of renal transplant recipients (RTR).

Ethics approval

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).

Study design

Non-randomised controlled trial.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

calcineurin inhibitors, sirolimus

Primary outcome measures

Changes in left ventricular mass (LVMi) at 12 months

Secondary outcome measures

Changes in serum creatinine as a measure of graft function at 12 months

Overall trial start date

01/06/2004

Overall trial end date

31/01/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

42

Participant exclusion criteria

1. Diabetic RTR
2. Patients receiving kidney transplant from living donors
3. Patients receiving dual kidney allograft

Recruitment start date

01/06/2004

Recruitment end date

31/01/2006

Locations

Countries of recruitment

Italy

Trial participating centre

L.go R.Benzi 10
Genova
16132
Italy

Sponsor information

Organisation

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

Sponsor details

c/o Dr Giuseppe Cannella
L. go R. Benzi 10
Genova
16132
Italy

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

The Italian National Health Service (Servizio Sanitario Nazionale [SSN]) (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22038336

Publication citations

  1. Results

    Paoletti E, Ratto E, Bellino D, Marsano L, Cassottana P, Cannella G, Effect of early conversion from CNI to sirolimus on outcomes in kidney transplant recipients with allograft dysfunction., J. Nephrol., 25, 5, 709-718, doi: 10.5301/jn.5000044.

Additional files

Editorial Notes