Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients
Phase 2
Completed
- Conditions
- Kidney Transplantation
- Interventions
- Drug: AEB071 200 mg b.i.d. / everolimusDrug: AEB071 300 mg b.i.d. / everolimus
- Registration Number
- NCT00820911
- 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
- 175
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AEB071 200 mg b.i.d. / everolimus AEB071 200 mg b.i.d. / everolimus - cyclosporine (reduced exposure) / everolimus cyclosporine (reduced exposure) / everolimus - AEB071 300 mg b.i.d. / everolimus AEB071 300 mg b.i.d. / everolimus -
- Primary Outcome Measures
Name Time Method renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formula at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation
- Secondary Outcome Measures
Name Time Method efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection, graft loss, death or loss to follow-up at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation
Trial Locations
- Locations (1)
Novartis Investigative Site
🇨🇳Taipei, Taiwan