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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00820911
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: cyclosporine (reduced exposure) / everolimus Drug: AEB071 300 mg b.i.d. / everolimus Drug: AEB071 200 mg b.i.d. / everolimus Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: cyclosporine (reduced exposure) / everolimus Drug: cyclosporine (reduced exposure) / everolimus
twice daily

Experimental: AEB071 300 mg b.i.d. / everolimus Drug: AEB071 300 mg b.i.d. / everolimus
twice daily

Experimental: AEB071 200 mg b.i.d. / everolimus Drug: AEB071 200 mg b.i.d. / everolimus
twice daily




Primary Outcome Measures :
  1. renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formula [ Time Frame: at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation ]

Secondary Outcome Measures :
  1. efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection, graft loss, death or loss to follow-up [ Time Frame: at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820911


Locations
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Argentina
Novartis Investigative Site
San Martin, Buenos Aires, Argentina, C1107BEA
Novartis Investigative Site
Cordoba, Argentina, X5022CPU
Australia, New South Wales
Novartis Investigative Site
Camperdown, New South Wales, Australia, 2050
Australia, South Australia
Novartis Investigative Site
Woodville, South Australia, Australia, 5011
Australia, Victoria
Novartis Investigative Site
Clayton, Victoria, Australia, 3168
Austria
Novartis Investigative Site
Innsbruck, Austria, A-6020
Belgium
Novartis Investigative Site
Gent, Belgium, 9000
Brazil
Novartis Investigative Site
Porto Alegre, RS, Brazil, 90020-090
Novartis Investigative Site
São Paulo, SP, Brazil, 04023-900
Colombia
Novartis Investigative Site
Bogotá, Colombia
Novartis Investigative Site
Cali, Colombia
Czech Republic
Novartis Investigative Site
Praha 4, Czech Republic, 140 00
France
Novartis Investigative Site
Brest, France, 29200
Novartis Investigative Site
Nantes Cedex, France, 44035
Novartis Investigative Site
Toulouse Cedex 4, France, 31054
Germany
Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Heidelberg, Germany, 69120
Italy
Novartis Investigative Site
Milano, MI, Italy, 20122
Novartis Investigative Site
Milano, MI, Italy, 20162
Netherlands
Novartis Investigative Site
Rotterdam, Netherlands, 3015 CE
Norway
Novartis Investigative Site
Oslo, Norway, 0424
Singapore
Novartis Investigative Site
Singapore, Singapore, 119074
Slovakia
Novartis Investigative Site
Kosice, Slovak Republic, Slovakia, 041 90
Novartis Investigative Site
Banska Bystrica, Slovakia, 975 17
Spain
Novartis Investigative Site
Hospitalet de Llobregat, Barcelona, Spain, 08907
Novartis Investigative Site
Madrid, Spain, 28034
Switzerland
Novartis Investigative Site
Zurich, Switzerland, 8091
Taiwan
Novartis Investigative Site
Taipei, Taiwan, 10002
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00820911    
Other Study ID Numbers: CAEB071A2206E1
2008-000531-18 ( EudraCT Number )
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Kidney transplant
AEB071
Additional relevant MeSH terms:
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Cyclosporine
Everolimus
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antineoplastic Agents