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

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

ChemIDplus related topics:

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	Novartis

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CAEB071A2203
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 October 03, 2008

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