Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients
- Registration Number
- NCT00504543
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 311
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AEB071 high dose with Cetican reduced dose AEB071 - AEB071 low dose with Cetican standard dose Certican - AEB071 high dose with Cetican reduced dose Certican - AEB071 low dose with Cetican standard dose AEB071 - Neoral Neoral -
- Primary Outcome Measures
Name Time Method Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection,(BPAR) graft loss, death or loss to follow-up, 3 months after transplantation. 12 months
- Secondary Outcome Measures
Name Time Method Primary efficacy failure endpoint,defined as a composite efficacy endpoint of treated(BPAR),graft loss, death or loss to follow-up of additional treatment regimen at Month 6; renal function at Month 3, Month 6 and Month 12 post transplant using GFR; PK 12 months
Trial Locations
- Locations (12)
Argentina
🇦🇷Buenos Aires, Argentina
Belgium
🇧🇪Gent, Belgium
Novartis Investigative Site
🇨🇳Taipie, Taiwan
Austria
🇦🇹Wein, Austria
Czech Republic
🇨🇿Praha, Czech Republic
Norway
🇳🇴Oslo, Norway
Brazil
🇧🇷Sao Paulo, Brazil
France
🇫🇷Toulouse, France
Netherlands
🇳🇱Rotterdam, Netherlands
Italy
🇮🇹Milano, Italy
Spain
🇪🇸Madrid, Spain
Australia
🇦🇺Sydney, Australia