24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients
Phase 2
Terminated
- Conditions
- Kidney Transplantation
- Interventions
- Drug: mycophenolic plus tacrolimus
- Registration Number
- NCT00555789
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 137
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 mycophenolic plus tacrolimus mycophenolic and tacrolimus 2 AEB071 mycophenolic and tacrolimus
- Primary Outcome Measures
Name Time Method Long term safety assessed by and renal safety defined by measuring renal function using Modification of Diet in Renal Disease (MDRD) formula for Glomerular Filtration Rate (GFR) beyond 12 months. three Yrs
- Secondary Outcome Measures
Name Time Method Efficacy assessed by: the incidence over 36 months of the composite endpoint of biopsy proven rejection ≥ 1A, graft loss, death, or loss to follow-up in the two study arms. Three yrs
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧Manchester, United Kingdom