Mycophenolate sodium vs Everolimus or Ciclosporin with Allograft Nephropathy as Outcome.
Completed
- Conditions
- prospective, open, randomized multicenter
- Registration Number
- NL-OMON25640
- Lead Sponsor
- MECANO Steering group Chair: S.Surachno/F.Bemelman
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 255
Inclusion Criteria
1. First or second renal transplant;
2. Female or male 18-70 years;
Exclusion Criteria
1. Double kidney transplants, kidney-pancreas transplants, 3rd or 4th transplant;
2. PRA > 50% historic or current;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Degree of inflammation and fibrosis and degree of arteriolar hyalinosis in renal biopsies taken at 6 and 24 months after implantation.
- Secondary Outcome Measures
Name Time Method 1. Vascular assesments by IMT and M-mode of carotis interna;<br /><br>2. Bloodpressure and number of antihypertensive drugs;<br /><br>3. Lipid profile;<br /><br>4. Renal allograft survival and function;<br /><br>5. Patient survival;<br /><br>6. Incidence of malignancies;<br /><br>7. Infectious complications.