24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients

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. Identifier: NCT00555789
Recruitment Status : Terminated
First Posted : November 9, 2007
Last Update Posted : August 7, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: AEB071 Drug: mycophenolic plus tacrolimus Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 24 Month Extension to a 12-month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients
Study Start Date : October 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
mycophenolic and tacrolimus
Drug: mycophenolic plus tacrolimus
720mg b.i.d. 2yrs
Experimental: 2
mycophenolic and tacrolimus
Drug: AEB071
200mg oral b.i.d.
Other Name: mycophenolic plus tacrolimus

Primary Outcome Measures :
  1. Long term safety assessed by and renal safety defined by measuring renal function using Modification of Diet in Renal Disease (MDRD) formula for Glomerular Filtration Rate (GFR) beyond 12 months. [ Time Frame: three Yrs ]

Secondary Outcome Measures :
  1. Efficacy assessed by: the incidence over 36 months of the composite endpoint of biopsy proven rejection ≥ 1A, graft loss, death, or loss to follow-up in the two study arms. [ Time Frame: Three yrs ]

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

Inclusion criteria:

  • Participation in core study CAEB071A2203
  • The patient has been maintained on AEB071/mycophenolic acid or tacrolimus/mycophenolic acid, consistent with their original randomization, at their core study Month 12 visit.
  • Women capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s).

Exclusion criteria:

  • Pregnancy. 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 identifier (NCT number): NCT00555789

United States, California
Novartis Investigative Site
San Francisco, California, United States, 94143-0780
United States, Wisconsin
Novartis Investigative Site
Madison, Wisconsin, United States, 53706
Novartis Investigative Site
Halifax, Canada, B3H 1V7
Novartis Investigative Site
Le Kremlin Bicetre, France, 94270
Novartis Investigative Site
Nantes, France, 44035
Novartis Investigative Site
Paris, France, 75015
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Toulouse, France, 31403
Novartis Investigative Site
Berlin, Germany, 13353
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Berlin, Germany
Novartis Investigative Site
Essen, Germany, 45122
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Koeln, Germany
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Bologna, Italy, 40138
Novartis Investigative Site
Firenze, Italy, 50134
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Padova, Italy, 35128
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Llobregat, Spain, 08907
Novartis Investigative Site
Madrid, Spain, 28041
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Malaga, Spain, 28041
Novartis Investigative Site
Valencia, Spain, 46017
Novartis Investigative Site
Basel, Switzerland, 4031
Novartis Investigative Site
Bern, Switzerland, 3010
Novartis Investigative Site
Zürich, Switzerland, 8091
United Kingdom
Novartis Investigative Site
Cardiff, United Kingdom, CF14 4XW
Novartis Investigative Site
Glasgow, United Kingdom, G11 6NT
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Manchester, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Novartis

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00555789     History of Changes
Other Study ID Numbers: AEB071A2203E1
First Posted: November 9, 2007    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: July 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
kidney transplantation
mycophenolic acid

Additional relevant MeSH terms:
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