Clinical trial NCT00820911: Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplantation
Keywords: Kidney transplant
AEB071
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

* Not applicable
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formula
timeFrame: at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation
Secondary outcomes:
measure: efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection, graft loss, death or loss to follow-up
timeFrame: at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation
Other outcomes:
Locations:
city: San Martin
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Camperdown
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Woodville
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Clayton
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
city: Cali
country: Colombia
facility: Novartis Investigative Site
city: Praha 4
country: Czech Republic
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: Nantes Cedex
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex 4
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Zurich
country: Switzerland
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: