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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00820911
First received: January 9, 2009
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  Purpose

This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: September 2008
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820911

  Show 45 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00820911     History of Changes
Other Study ID Numbers: CAEB071A2206E1, 2008-000531-18
Study First Received: January 9, 2009
Last Updated: October 5, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic

Keywords provided by Novartis:
Kidney transplant
AEB071

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Everolimus
Sirolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 18, 2013