Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00403416

Purpose

This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.

Condition	Intervention	Phase
Kidney Transplantation	Drug: AEB071	Phase I Phase II

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus Tacrolimus anhydrous Basiliximab Mycophenolic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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:

Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up at 6 months

Secondary Outcome Measures:

Renal function at Month 6 post-transplant Modification of diet in renal disease (MDRD) formula for Glomerular Filtration Rate)
Primary efficacy failure, defined as a composite efficacy endpoint of treated BPAR, graft loss, death or loss to follow-up at 3 and 12 months
Various efficacy endpoints at Month 3, 6 and 12, using treated BPAR, treated acute rejection (AR), death, graft loss, loss to follow-up and combinations thereof.
Changes in renal function (GFR) after replacing tacrolimus by myfortic in the AEB071treatment arms (from Month 3 to Month 6)
Safety and tolerability at 3, 6 and 12 months

Estimated Enrollment:	195
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion criteria

Male and female patients of any race 18 years or older
Adult recipients of a kidney transplant from a deceased or from a living donor
Recipients of a functioning Kidney:. Graft must be functional no later than 36h after transplantation.

Exclusion criteria

Need for medication prohibited by the protocol
Patients or donors infected with hepatitis B or C, or with HIV.
Patients with a history of cancer
Patients with severe systemic infections Patients with heart diseases (own or family history) which are associated with an increased risk for arrhythmias.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403416

Locations

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-0780
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106-5048
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792-7375
Canada
QE II Health Sciences Center
Halifax, Canada, B3H 1V7
France
CHU de Rangueil
Toulouse, France, 31403
Hopital Hotel Dieu
Nantes, France, 44035
Hopital Necker
Paris, France, 75015
Hopital Kremlin Bicetre
Le Kremlin Bicetre, France, 94270
Germany
Universitaetsklinik Charite
Berlin, Germany, 10117
Klinikum der Humboldt Universitat Charite
Berlin, Germany, 13353
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Univ. - Klinikum Heidelberg
Heidelberg, Germany, 69120
Staedt. Krankenhaus Koeln-Merheim
Koeln, Germany, 51109
Universitaetsklinikum Essen
Essen, Germany, 45122
Italy
Azienda Ospedaliera di Padova - Universita degli Studi
Padova, Italy, 35128
Az. Osp. Di Bologna Polici. S. Orsola - Malpighi
Bologna, Italy, 40138
Azienda Opedaliera Careggi - Universita degli Studi
Firenze, Italy, 50134
Spain
Ciutat Santitaria I Univessitaria de Bellvitge
Hospitalet de Llobregat, Spain, 08907
Hospital Doctor Peset
Valencia, Spain, 46017
Complejo Hospitalario Carlos Haya
Malaga, Spain, 28041
Hospital 12 de Octubre
Madrid, Spain, 28041
Switzerland
Universitätsspital Zürich
Zürich, Switzerland, 8091
Inselspital Bern
Bern, Switzerland, 3010
Universitatsspital Basel
Basel, Switzerland, 4031
United Kingdom
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Manchester Royal Infirmary
Manchester, United Kingdom
Saint George's University of London
London, United Kingdom
Western Infirmary
Glasgow, United Kingdom, G11 6NT

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CAEB071A2203
Study First Received:	November 22, 2006
Last Updated:	March 18, 2008
ClinicalTrials.gov Identifier:	NCT00403416
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; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; Canada: Health Canada; Switzerland: Swissmedic

Keywords provided by Novartis:

AEB071
Tacrolimus
Mycophenolic acid
Basiliximab

Rejection
Kidney function
Immunosuppression

Study placed in the following topic categories:

Basiliximab
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 14, 2009