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Mycophenolate sodium vs Everolimus or Ciclosporin with Allograft Nephropathy as Outcome.


- candidate number1933
- NTR NumberNTR567
- ISRCTNISRCTN69188731
- Date ISRCTN created14-feb-2006
- date ISRCTN requested3-feb-2006
- Date Registered NTR17-jan-2006
- Secondary IDsN/A 
- Public TitleMycophenolate sodium vs Everolimus or Ciclosporin with Allograft Nephropathy as Outcome.
- 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.
- ACRONYMMECANO
- hypothesisBy achieving optimal immunosuppression with minimal sideeffects due to controled drugexposure by target AUC's we expect reduction of druginduced damage on kidney and cardiovascular system. Three drugs will be subject of study: ciclosporin, mycophenolate and everolimus.
- Healt Condition(s) or Problem(s) studiedRenal transplant
- Inclusion criteria1. 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 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2004
- planned closingdate1-jan-2008
- Target number of participants255
- InterventionsBy 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 and AUC guided ciclosporin treatment;
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 treatmentarms no separate control group is defined because no data exists adressing the "golden standard" treatment after renal transplantation.
- Primary outcomeDegree of inflammation and fibrosis and degree of arteriolar hyalinosis in renal biopsies taken at 6 and 24 months after implantation.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES S. Surachno
- CONTACT for SCIENTIFIC QUERIESDr. F. Bemelman
- Sponsor/Initiator Academic Medical Center (AMC), Renal Transplant Unit, Leiden University Medical Center (LUMC), Renal transplant unit, University Medical Center Groningen (UMCG), Renal transplant unit
- Funding
(Source(s) of Monetary or Material Support)
Novartis Pharma B.V.
- PublicationsN/A
- Brief summaryThis study compares the results on changes of renal allograft histology by optimal use of ciclosporin, mycophenolate sodium and everolimus ( primary endpoints). Furthermore cardiovascular, infectious and oncologic endpoints will be assessed in each group and compared to each other.
- Main changes (audit trail)
- RECORD17-jan-2006 - 9-dec-2010


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