NCT00555789
Terminated
Phase 2
A 24 Month Extension to a 12-month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients
ConditionsKidney Transplantation
Overview
- Phase
- Phase 2
- Intervention
- mycophenolic plus tacrolimus
- Conditions
- Kidney Transplantation
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 137
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
mycophenolic and tacrolimus
Intervention: mycophenolic plus tacrolimus
2
mycophenolic and tacrolimus
Intervention: AEB071
Outcomes
Primary Outcomes
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.
Time Frame: three Yrs
Secondary Outcomes
- 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)
Study Sites (1)
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