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NCT00820911 Clinical Trial

Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients

Kidney Transplantation Clinical Trial

Official title:
An Extension to a 12-month, Open-label, Randomised, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00820911
Other study ID # CAEB071A2206E1
Secondary ID 2008-000531-18
Status Completed
Phase Phase 2
First received January 9, 2009
Last updated February 22, 2017
Start date September 2008
Est. completion date July 2012

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

Recruitment information / eligibility
Status Completed
Enrollment 175
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion criteria:

- Patient has been maintained on study drug for 12 months in the core study

Exclusion criteria:

- Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• cyclosporine (reduced exposure) / everolimus
twice daily
• AEB071 300 mg b.i.d. / everolimus
twice daily
• AEB071 200 mg b.i.d. / everolimus
twice daily

Locations
Country Name City State
Argentina Novartis Investigative Site Cordoba
Argentina Novartis Investigative Site San Martin Buenos Aires
Australia Novartis Investigative Site Camperdown New South Wales
Australia Novartis Investigative Site Clayton Victoria
Australia Novartis Investigative Site Woodville South Australia
Austria Novartis Investigative Site Innsbruck
Belgium Novartis Investigative Site Gent
Brazil Novartis Investigative Site Porto Alegre RS
Brazil Novartis Investigative Site São Paulo SP
Colombia Novartis Investigative Site Bogotá
Colombia Novartis Investigative Site Cali
Czech Republic Novartis Investigative Site Praha 4
France Novartis Investigative Site Brest
France Novartis Investigative Site Nantes Cedex
France Novartis Investigative Site Toulouse Cedex 4
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Heidelberg
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Milano MI
Netherlands Novartis Investigative Site Rotterdam
Norway Novartis Investigative Site Oslo
Singapore Novartis Investigative Site Singapore
Slovakia Novartis Investigative Site Banska Bystrica
Slovakia Novartis Investigative Site Kosice Slovak Republic
Spain Novartis Investigative Site Hospitalet de Llobregat Barcelona
Spain Novartis Investigative Site Madrid
Switzerland Novartis Investigative Site Zurich
Taiwan Novartis Investigative Site Taipei

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Brazil,  Colombia,  Czech Republic,  France,  Germany,  Italy,  Netherlands,  Norway,  Singapore,  Slovakia,  Spain,  Switzerland,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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