Extension study to the multicenter, open-label, randomized, controlled study CRAD001H2304 to evaluate the long-term efficacy and safety of concentrationcontrolled everolimus in liver transplant recipients.
Phase 3
Completed
- Conditions
- Impaired renal function after liver transplantation1001965410038430
- Registration Number
- NL-OMON34870
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
Inclusion Criteria
Completed Month 24 visit of core study and continuously being treated with assigned
regimen.
Exclusion Criteria
1. Patients with clinically significant systemic infection requiring active use of IV
antibiotics at Month 24.
2. Patients who are in a critical care setting at Month 24 requiring life support measures
such as mechanical ventilation, dialysis, requirement of vasopressor agents.
3. Women of child-bearing potential, unless they meet certain criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Renal function;<br /><br>• The composite efficacy endpoint of graft loss or death;<br /><br>• The composite efficacy endpoint of treated biopsy proven acute rejection<br /><br>(BPAR), graft loss, or death;<br /><br>• The rate of progression of HCV related allograft fibrosis.</p><br>
- Secondary Outcome Measures
Name Time Method