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Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: June 26, 2007
Last updated: September 22, 2016
Last verified: September 2016
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.

Condition Intervention Phase
Kidney Transplantation
Drug: AEB071
Phase 1
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, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, 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:
  • Efficacy will be defined using a composite efficacy failure end point (treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up) between treatment and control arms

Secondary Outcome Measures:
  • Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies

Enrollment: 124
Study Start Date: January 2007
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Male and female patients of any race 18 years or older
  • Adult recipients of kidney transplant from a deceased or living donor
  • Recipients of a functioning kidney within 24 hours post transplant


  • Need for medication prohibited by the protocol
  • Patients or donors infected with Hepatitis B,C or HIV
  • Patients with a history of cancer within last 5 years
  • Patients with history of significant cardiac disorder
  • Patients of high-risk immunological status

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00492869

  Show 41 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00492869     History of Changes
Other Study ID Numbers: CAEB071A2207 
Study First Received: June 26, 2007
Last Updated: September 22, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
kidney transplantation

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents processed this record on October 21, 2016