Minimization of maintenance immunosuppression early after renal transplantation.
Suspended
- Conditions
- renal transplantation, renal failureciclosporin, allograft nephropathy, everolimus, mycophenolate mofetyl.Niertransplantatie, ciclosporine, cardiovasculaire bijwerkingen
- Registration Number
- NL-OMON22724
- Lead Sponsor
- ovartis Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 270
Inclusion Criteria
1. 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;
Exclusion Criteria
1. Patients with a HLA-identical sibling donor;
2. a third or a fourth transplant;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The 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 Outcome Measures
Name Time Method 1. Cardiovascular (surrogate) endpoints; IMT Intima/Media Thickness of the a. carotis interna;<br /><br>2. Blood pressure and the number of antihypertensives;<br /><br>3. Lipid profile;<br /><br>4. Renal allograft survival and function (Nankivell), and patient survival;<br /><br>5. The incidence of malignancies;<br /><br>6. Infectious complications;<br /><br>7. Miscellaneous;<br /> <br>fasting glucose, HbA1c, uric acid<br>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.<br>