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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00504543 |
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: AEB071 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official 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. |
Estimated Enrollment: | 258 |
Study Start Date: | July 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion criteria
Exclusion criteria
Contact: novartis | 41613241111 |
Argentina | |
Argentina | Recruiting |
Buenos Aires, Argentina, 1425 | |
Contact: novartis 41613241111 | |
Argentina | Recruiting |
Buenos Aires, Argentina, 1107 | |
Contact: Novartis 41613241111 | |
Australia | |
Australia | Recruiting |
Sydney, Australia, 2050 | |
Contact: novartis 41643241111 | |
Australia | Recruiting |
Sydney, Australia, 5011 | |
Contact: novartis 41613241111 | |
Austria | |
Austria | Recruiting |
Wein, Austria, 1090 | |
Contact: Novartis 41613241111 | |
Austria | Recruiting |
Innsbruck, Austria, 6020 | |
Contact: novartis 41613241111 | |
Belgium | |
Belgium | Recruiting |
Gent, Belgium, 9000 | |
Contact: novartis 41613241111 | |
Brazil | |
Brazil | Recruiting |
Sao Paulo, Brazil, 04038-002 | |
Contact: Novartis 41613241111 | |
Czech Republic | |
Czech Republic | Recruiting |
Praha, Czech Republic, 14021 | |
Contact: Novartis 41613241111 | |
France | |
France | Recruiting |
Toulouse, France, 31055 | |
Contact: Novartis 41613241111 | |
France | Recruiting |
Lille Cedex, France, 59037 | |
Contact: novartis 41613241111 | |
Italy | |
Italy | Recruiting |
Milano, Italy, 20122 | |
Contact: Novartis 41613241111 | |
Italy | Recruiting |
Milano, Italy, 20100 | |
Contact: Novartis 41613241111 | |
Netherlands | |
Netherlands | Recruiting |
Rotterdam, Netherlands, 3000CA | |
Contact: Novartis 41613241111 | |
Norway | |
Norway | Recruiting |
Oslo, Norway, 0027 | |
Contact: Novartis 41613241111 | |
Spain | |
Spain | Recruiting |
Barcelona, Spain, 08024 | |
Contact: novartis 41613241111 | |
Spain | Recruiting |
Madrid, Spain, 28034 | |
Contact: Novartis 41613241111 |
Study Director: | Novartis | Novartis |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CAEB071A2206 |
Study First Received: | July 19, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00504543 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Kidney transplant, AEB071 |
Everolimus Basiliximab Signs and Symptoms Cyclosporine |
Immunologic Factors Immunosuppressive Agents Cyclosporins |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Cyclosporins Pharmacologic Actions |