prospective, open, randomized multicenter
Conditions
Interventions
By achieving stable state 6 months after renal transplantation a baseline renal allograft biopsy is performed and randomisation in one of the three arms of the study takes place.
Arm 1: prednisolon
Arm 2 : prednisolon and AUC guided mycophenolate mofetil sodium treatment
Arm 3: prednisolon and AUC guided everolimus treatment. All treatment arm have a duration of 18 month whereafter a final renal allograft biopsy is performed.
It has to be noted that for the 3 treatme
Sponsors
MECANO Steering group
Chair: S.Surachno/F.Bemelman
Eligibility
Inclusion criteria
Inclusion criteria: 1. First or second renal transplant; 2. Female or male 18-70 years; 3. Cadaveric or non-HLA identical living donor; 4. Understands risks and purpose of study; 5. written informed consent.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of inflammation and fibrosis and degree of arteriolar hyalinosis in renal biopsies taken at 6 and 24 months after implantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Vascular assesments by IMT and M-mode of carotis interna; 2. Bloodpressure and number of antihypertensive drugs; 3. Lipid profile; 4. Renal allograft survival and function; 5. Patient survival; 6. Incidence of malignancies; 7. Infectious complications. | — |
Contacts
Public ContactS. Surachno
Academic Medical Center (AMC), Renal transplant unit, P.O. Box 22660
Outcome results
None listed