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AEB071 Extension Study in Renal Transplant Recipients
NCT00555789Phase 2
Key facts
- Status
- Terminated
- Start
- Oct 2007
- Primary completion
- Mar 2008
- Countries
- 8
- Sponsor
- Novartis
- Modality
- Small Molecules
- Drugs
- sotrastaurin
- Conditions
- kidney transplantation
01
Overview
Phase 2, randomised, open-label trial of sotrastaurin in kidney transplantation (2 arms), sponsored by Novartis. 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) at 3 years. Started Oct 2007; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Control Arm
Tacrolimus + Mycophenolic Acid (Continued from core study)
Experimental Arm
Sotrastaurin (AEB071) + Mycophenolic Acid (Continued from core study, converted from Tacrolimus at Month 3 of core)
03
Who it enrols
Patients who participated in the core study CAEB071A2203 and were maintained on their randomized treatment (AEB071/mycophenolic acid or tacrolimus/mycophenolic acid) at Month 12.
04
Endpoints
Primary
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)
Secondary
Incidence of the composite endpoint of biopsy proven rejection >= 1A, graft loss, death, or loss to follow-up
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