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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492869
First Posted: June 27, 2007
Last Update Posted: September 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 ( Novartis Pharmaceuticals ):

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)
  Eligibility

Information from the National Library of Medicine

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

Inclusion:

  • 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

Exclusion:

  • 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
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): NCT00492869


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00492869     History of Changes
Other Study ID Numbers: CAEB071A2207
First Submitted: June 26, 2007
First Posted: June 27, 2007
Last Update Posted: September 23, 2016
Last Verified: September 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
kidney transplantation
rejection
AEB071
tacrolimus
mycophenolic
basiliximab
immunosuppression

Additional relevant MeSH terms:
Tacrolimus
Basiliximab
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents