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 - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00555789

Purpose

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	Intervention	Phase
Kidney Transplantation	Drug: AEB071 Drug: mycophenolic	Phase II

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus Tacrolimus anhydrous Mycophenolic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment
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

Further study details as provided by Novartis:

Primary Outcome Measures:

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:

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 ]

Estimated Enrollment:	130
Study Start Date:	October 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator mycophenolic and tacrolimus	Drug: mycophenolic 720mg b.i.d. 2yrs
2: Experimental mycophenolic and AEB071	Drug: AEB071 200mg oral b.i.d.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555789

Locations

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

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	AEB071A2203E1
Study First Received:	November 8, 2007
Last Updated:	March 18, 2008
ClinicalTrials.gov Identifier:	NCT00555789
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Italy: Ministry of Health; France: Afssaps - French Health Products Safety Agency; Canada: Health Canada; Spain: Spanish Agency of Medicines; Switzerland: Swissmedic

Keywords provided by Novartis:

kidney transplantation
rejection
AEB071

tacrolimus
mycophenolic acid
immunosuppression

Study placed in the following topic categories:

Mycophenolic Acid
Tacrolimus

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009