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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: February 22, 2017
Last verified: February 2017
  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: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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:


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 ]

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 ]

Enrollment: 175
Study Start Date: September 2008
Study Completion Date: July 2012
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 to 75 Years   (Adult, Senior)
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:

  • Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820911

  Show 28 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00820911     History of Changes
Other Study ID Numbers: CAEB071A2206E1
2008-000531-18 ( EudraCT Number )
Study First Received: January 9, 2009
Last Updated: February 22, 2017

Keywords provided by Novartis:
Kidney transplant
AEB071

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

ClinicalTrials.gov processed this record on May 22, 2017