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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00820911




Registration number
NCT00820911
Ethics application status
Date submitted
9/01/2009
Date registered
12/01/2009
Date last updated
24/02/2017

Titles & IDs
Public title
Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients
Scientific 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
Secondary ID [1] 0 0
2008-000531-18
Secondary ID [2] 0 0
CAEB071A2206E1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cyclosporine (reduced exposure) / everolimus
Treatment: Drugs - AEB071 300 mg b.i.d. / everolimus
Treatment: Drugs - AEB071 200 mg b.i.d. / everolimus

Active Comparator: cyclosporine (reduced exposure) / everolimus -

Experimental: AEB071 300 mg b.i.d. / everolimus -

Experimental: AEB071 200 mg b.i.d. / everolimus -


Treatment: Drugs: cyclosporine (reduced exposure) / everolimus
twice daily

Treatment: Drugs: AEB071 300 mg b.i.d. / everolimus
twice daily

Treatment: Drugs: AEB071 200 mg b.i.d. / everolimus
twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formula
Timepoint [1] 0 0
at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation
Secondary outcome [1] 0 0
efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection, graft loss, death or loss to follow-up
Timepoint [1] 0 0
at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation

Eligibility
Key inclusion criteria
Inclusion criteria:

- Patient has been maintained on study drug for 12 months in the core study
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Not applicable

- Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2012
Sample size
Target
Accrual to date
Final
175
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Camperdown
Recruitment hospital [2] 0 0
Novartis Investigative Site - Woodville
Recruitment hospital [3] 0 0
Novartis Investigative Site - Clayton
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Cordoba
Country [3] 0 0
Austria
State/province [3] 0 0
Innsbruck
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Brazil
State/province [5] 0 0
RS
Country [6] 0 0
Brazil
State/province [6] 0 0
SP
Country [7] 0 0
Colombia
State/province [7] 0 0
Bogotá
Country [8] 0 0
Colombia
State/province [8] 0 0
Cali
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Praha 4
Country [10] 0 0
France
State/province [10] 0 0
Brest
Country [11] 0 0
France
State/province [11] 0 0
Nantes Cedex
Country [12] 0 0
France
State/province [12] 0 0
Toulouse Cedex 4
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Heidelberg
Country [15] 0 0
Italy
State/province [15] 0 0
MI
Country [16] 0 0
Netherlands
State/province [16] 0 0
Rotterdam
Country [17] 0 0
Norway
State/province [17] 0 0
Oslo
Country [18] 0 0
Singapore
State/province [18] 0 0
Singapore
Country [19] 0 0
Slovakia
State/province [19] 0 0
Slovak Republic
Country [20] 0 0
Slovakia
State/province [20] 0 0
Banska Bystrica
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Spain
State/province [22] 0 0
Madrid
Country [23] 0 0
Switzerland
State/province [23] 0 0
Zurich
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00820911
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries