Mycophenolate sodium versus Everolimus or Cyclosporine with Allograft Nephropathy as Outcome

ISRCTN ISRCTN69188731
DOI https://doi.org/10.1186/ISRCTN69188731
Secondary identifying numbers NTR567
Submission date
14/02/2006
Registration date
14/02/2006
Last edited
08/01/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr S. Surachno
Scientific

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

Study information

Study designMulticentre, randomised, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA 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.
Study acronymMECANO
Study objectivesBy 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(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedRenal transplant
InterventionBy 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)mycophenolate sodium, everolimus, cyclosporine
Primary outcome measureDegree of inflammation and fibrosis and degree of arteriolar hyalinosis in renal biopsies taken at 6 and 24 months after implantation.
Secondary outcome measures1. 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 study start date01/01/2004
Completion date01/01/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexBoth
Target number of participants255
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2004
Date of final enrolment01/01/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Center (AMC), Renal Transplant Unit (The Netherlands)
Hospital/treatment centre

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Industry

Novartis Pharma BV (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article retrospective substudy results 01/05/2014 Yes No