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

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 plus tacrolimus	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Mycophenolic acid Mycophenolate sodium Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate mofetil

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

Enrollment:	137
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
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

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
Paris, France, 75015
Novartis Investigative Site
Toulouse, France, 31403
Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Essen, Germany, 45122
Novartis Investigative Site
Hannover, Germany, 30625
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
Madrid, Spain, 28041
Novartis Investigative Site
Malaga, Spain, 28041
Novartis Investigative Site
Valencia, Spain, 46017
Switzerland
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

Investigators

Study Director:

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00555789 History of Changes
Other Study ID Numbers:	AEB071A2203E1
Study First Received:	November 8, 2007
Last Updated:	July 31, 2012
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Canada: Health Canada Spain: Spanish Agency of Medicines Switzerland: Swissmedic

Keywords provided by Novartis:

kidney transplantation
rejection
AEB071

tacrolimus
mycophenolic acid
immunosuppression

Additional relevant MeSH terms:

Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013