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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00504543
First received: July 19, 2007
Last updated: May 1, 2012
Last verified: May 2012
  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: AEB071
Drug: Certican
Drug: Neoral
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Novartis:

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

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

Enrollment: 311
Study Start Date: July 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT00504543

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00504543     History of Changes
Other Study ID Numbers: CAEB071A2206
Study First Received: July 19, 2007
Last Updated: May 1, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Novartis:
Kidney transplant, AEB071

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Everolimus
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

ClinicalTrials.gov processed this record on August 26, 2014