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Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients (AEB071)

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ClinicalTrials.gov Identifier: NCT00504543
Recruitment Status : Completed
First Posted : July 20, 2007
Last Update Posted : November 18, 2016
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: AEB071 Drug: Certican Drug: Neoral Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : July 2007
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Neoral Drug: Neoral
twice daily

Active Comparator: AEB071 high dose with Cetican reduced dose Drug: AEB071
oral, twice daily

Drug: Certican
twice daily

Active Comparator: AEB071 low dose with Cetican standard dose Drug: AEB071
oral, twice daily

Drug: Certican
twice daily




Primary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Male and female patients 18 years or older
  • Recipients of first kidney transplant from a deceased or living not related donor

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

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): NCT00504543


  Show 26 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis

Additional Information:
Publications of Results:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00504543     History of Changes
Other Study ID Numbers: CAEB071A2206
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Kidney transplant, AEB071

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Everolimus
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