Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR567
Study information
Scientific title
A prospective, open, randomized, multicenter study comparing the effects of everolimus versus mycophenolate sodium as compared to ciclosporin as maintenance therapy in renal allograft recipients, on chronic allograft damage and cardiovascular parameters.
Acronym
MECANO
Study hypothesis
By achieving optimal immunosuppression with minimal side-effects due to controlled drug exposure by target AUCs, we expect reduction of drug-induced damage on kidney and cardiovascular system. Three drugs will be the subject of the study: cyclosporine, mycophenolate and everolimus.
Ethics approval
Received from local medical ethics committee
Study design
Multicentre, randomised, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Renal transplant
Intervention
By achieving stable state 6 months after renal transplantation, a baseline renal allograft biopsy is performed and randomisation to one of the three arms of the study takes place.
Arm 1: prednisolone and AUC guided cyclosporine treatment
Arm 2 : prednisolone and AUC guided mycophenolate mofetil sodium treatment
Arm 3: prednisolone and AUC guided everolimus
All treatment arms have a duration of 18 months where after a final renal allograft biopsy is performed.
It has to be noted that for the 3 treatment arms no separate control group is defined because no data exists addressing the 'golden standard' treatment after renal transplantation.
Intervention type
Drug
Phase
Not Specified
Drug names
mycophenolate sodium, everolimus, cyclosporine
Primary outcome measure
Degree of inflammation and fibrosis and degree of arteriolar hyalinosis in renal biopsies taken at 6 and 24 months after implantation.
Secondary outcome measures
1. Vascular assessments by IMT and M-mode of carotis interna
2. Blood pressure and number of antihypertensive drugs
3. Lipid profile
4. Renal allograft survival and function
5. Patient survival
6. Incidence of malignancies
7. Infectious complications
Overall trial start date
01/01/2004
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. First or second renal transplant
2. Female or male 18-70 years old
3. Cadaveric or non-HLA identical living donor
4. Understands risks and purpose of study
5. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
255
Participant exclusion criteria
1. Double kidney transplants, kidney-pancreas transplants, 3rd or 4th transplant
2. PRA >50% historic or current
3. Pregnancy or unwilling to use contraception during the study
4. Cholesterol >8.5 mmol/l
5. History of therapy resistance against HMG co-reductase inhibitors
Recruitment start date
01/01/2004
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
Funders
Funder type
Industry
Funder name
Novartis Pharma BV (Netherlands)
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
Basic results (scientific)
Publication list
2014 retrospective substudy results in: http://www.ncbi.nlm.nih.gov/pubmed/24484452