Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients
NCT00504543 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 311
Last updated 2016-11-18
Summary
This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.
Conditions
- Kidney Transplantation
Interventions
- DRUG
-
AEB071
oral, twice daily
- DRUG
-
Certican
twice daily
- DRUG
-
Neoral
twice daily
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis · Novartis
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-07-31
- Primary Completion
- 2011-04-30
- Completion
- 2011-04-30
Countries
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Colombia
- Czechia
- France
- Germany
- Italy
- Netherlands
- Norway
- Singapore
- Slovakia
- Spain
- Switzerland
- Taiwan
Study Locations
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