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Minimization of maintenance immunosuppression early after renal transplantation.


- candidate number5068
- NTR NumberNTR1615
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jan-2009
- Secondary IDskwkirjjn 
- Public TitleMinimization of maintenance immunosuppression early after renal transplantation.
- Scientific TitleMinimization of maintenance immunosuppression early after renal transplantation to prednisolone and everolimus is effective.
- ACRONYMMECANO
- hypothesisChronic allograft nephropathy is the main cause of long-term renal transplant failure. The pathogenesis involves amongst others calcineurin inhibitors. We performed a multicenter randomized trial to study the effects of withdrawal of ciclosporin (CsA) from a triple immunosuppressive regimen at 6 months after transplantation. This study is designed to offer the patients “tailored made” immunosuppressive therapy aiming for a very low incidence of acute rejection and a minimum of side effects, such as cardiovascular damage and nefrotoxicity.
- Healt Condition(s) or Problem(s) studiedRenal transplant , Renal disease
- Inclusion criteria1. Patients, between the age of 18 en 70 years, receiving a first or second renal transplant;
2. Patients had to understand the purpose and risks of the study;
3. Patients had to give written informed consent.
- Exclusion criteria1. Patients with a HLA-identical sibling donor;
2. a third or a fourth transplant;
3. current or historical panel reactive antibodies of more than 50%;
4. female patients unwilling to use adequate contraception during the study;
5. a cholesterol > 8.5 mmol/l despite HMG co-A reductase inhibition.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2005
- planned closingdate
- Target number of participants270
- InterventionsThe effects of longtime maintenance therapy with everolimus or with MPS in combination with prednisolone will be evaluated. Both drugs will be given orally. Dosages will be guided by calculating drug exposure, using a validated computer model based on a limited sampling strategy. Reference therapy consists of ciclosporin in combination with prednisolone. Drug exposure of ciclosporin will be monitored closely as well.
- Primary outcomeThe degree of inflammation and fibrosis and the degree of arteriolar hyalinosis in renal biopsies taken at 6 and 24 months after implantation. Biopsies will be evaluated according to the Banff ‘97 Criteria for Renal Allograft Biopsy Interpretation (appendix II). Quantitative morphometric analysis of interstitial fibrous tissue will be performed using the digital image analysis technique
- Secondary outcome1. Cardiovascular (surrogate) endpoints; IMT Intima/Media Thickness of the a. carotis interna;
2. Blood pressure and the number of antihypertensives;
3. Lipid profile;
4. Renal allograft survival and function (Nankivell), and patient survival;
5. The incidence of malignancies;
6. Infectious complications;
7. Miscellaneous;
fasting glucose, HbA1c, uric acid MPA-levels and IMPDH activity over time, everolimus levels. MPA and everolimus levels over time (AUCs) will be correlated to graft function, rejection episodes and trough levels.
- TimepointsPre-Tx1 Week
“2” Week
4-6 Month
3 Month
6 Month
7 Month
12 Month
18 Month
24 Month.
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESDr. F. Bemelman
- CONTACT for SCIENTIFIC QUERIESDr. F. Bemelman
- Sponsor/Initiator Novartis Pharma AG
- Funding
(Source(s) of Monetary or Material Support)
Novartis Pharma B.V.
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD6-jan-2009 - 8-feb-2009


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