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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00504543




Registration number
NCT00504543
Ethics application status
Date submitted
19/07/2007
Date registered
20/07/2007
Date last updated
18/11/2016

Titles & IDs
Public title
Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients
Scientific title
A 12 Month Open-label, Randomized, Multicenter, Sequential Cohort-group, 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
CAEB071A2206
Universal Trial Number (UTN)
Trial acronym
AEB071
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 - AEB071
Treatment: Drugs - Certican
Treatment: Drugs - Neoral

Active comparator: Neoral -

Active comparator: AEB071 high dose with Cetican reduced dose -

Active comparator: AEB071 low dose with Cetican standard dose -


Treatment: Drugs: AEB071
oral, twice daily

Treatment: Drugs: Certican
twice daily

Treatment: Drugs: Neoral
twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection,(BPAR) graft loss, death or loss to follow-up, 3 months after transplantation.
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Primary efficacy failure endpoint,defined as a composite efficacy endpoint of treated(BPAR),graft loss, death or loss to follow-up of additional treatment regimen at Month 6; renal function at Month 3, Month 6 and Month 12 post transplant using GFR; PK
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
Inclusion criteria

* Male and female patients 18 years or older
* Recipients of first kidney transplant from a deceased or living not related donor
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

* Need for medication prohibited in the study
* Patients with heart disease (own or family history)
* Patients or donor HIV, Hepatitis B (HBsAg) or Hepatitis C (HCV) positive
* Patients with high immunological risks
* Patients with a history of cancer
* 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
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2011
Sample size
Target
Accrual to date
Final
311
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Australia - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
5011 - Sydney
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Wein
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
Colombia
State/province [6] 0 0
Bogota
Country [7] 0 0
Colombia
State/province [7] 0 0
Cali
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Praha
Country [9] 0 0
France
State/province [9] 0 0
Lille Cedex
Country [10] 0 0
France
State/province [10] 0 0
Toulouse
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Heidelberg
Country [13] 0 0
Italy
State/province [13] 0 0
Milano
Country [14] 0 0
Netherlands
State/province [14] 0 0
Rotterdam
Country [15] 0 0
Norway
State/province [15] 0 0
Oslo
Country [16] 0 0
Singapore
State/province [16] 0 0
Singapore
Country [17] 0 0
Slovakia
State/province [17] 0 0
Banska Bystrica
Country [18] 0 0
Slovakia
State/province [18] 0 0
Kosice
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Switzerland
State/province [21] 0 0
Zurich
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taipie

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/study/NCT00504543
Trial related presentations / publications
Tedesco-Silva H, Kho MM, Hartmann A, Vitko S, Russ G, Rostaing L, Budde K, Campistol JM, Eris J, Krishnan I, Gopalakrishnan U, Klupp J. Sotrastaurin in calcineurin inhibitor-free regimen using everolimus in de novo kidney transplant recipients. Am J Transplant. 2013 Jul;13(7):1757-68. doi: 10.1111/ajt.12255. Epub 2013 May 9.
Public notes

Contacts
Principal investigator
Name 0 0
Novartis
Address 0 0
Novartis
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00504543