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
• 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

Related Conditions & MeSH terms

• Kidney Transplantation

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

External Links

•   Results of study CAEB071A2206E1 from Novartis clinical trials website