Condition category
Surgery
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
08/01/2015
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 S. Surachno

ORCID ID

Contact details

Academic Medical Center
Renal transplant unit
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

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 measures

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

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

Sponsor information

Organisation

Academic Medical Center (AMC), Renal Transplant Unit (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2014 retrospective substudy results in: http://www.ncbi.nlm.nih.gov/pubmed/24484452

Publication citations

Additional files

Editorial Notes