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
Scientific
Academic Medical Center
Renal transplant unit
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Study information
| Study design | Multicentre, randomised, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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. |
| Study acronym | MECANO |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2004 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 255 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Center (AMC), Renal Transplant Unit (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
