Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients

This study is currently recruiting participants.

Verified by Novartis, January 2009

First Received: July 19, 2007 Last Updated: January 9, 2009 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00504543

Purpose

This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

Condition	Intervention	Phase
Kidney Transplantation	Drug: AEB071	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12 Month Open-Label, Randomized, Multicenter, Sequential Cohort-Group, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients.

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cyclosporine Cyclosporin AEB 071

U.S. FDA Resources

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, 3 months after transplantation.

Secondary Outcome Measures:

Primary efficacy failure endpoint,defined as a composite efficacy endpoint of treated(BPAR),graft loss, death or loss to follow-up of additional treatment regimen at 3 Months after transplantation & for all regimens at Month 12 renal function; PK

Estimated Enrollment:	258
Study Start Date:	July 2007

Eligibility

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

Criteria

Inclusion criteria

Male and female patients 18 years or older
Recipients of first kidney transplant from a deceased or living not related donor

Exclusion criteria

Need for medication prohibited in the study
Patients with heart disease (own or family history)
Patients or donor HIV, Hepatitis B (HBsAg) or Hepatitis C (HCV) positive
Patients with high immunological risks
Patients with a history of cancer
Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504543

Contacts

Contact: novartis

41613241111

Locations

Argentina
Argentina	Recruiting
Buenos Aires, Argentina, 1425
Contact: novartis 41613241111
Argentina	Recruiting
Buenos Aires, Argentina, 1107
Contact: Novartis 41613241111
Australia
Australia	Recruiting
Sydney, Australia, 2050
Contact: novartis 41643241111
Australia	Recruiting
Sydney, Australia, 5011
Contact: novartis 41613241111
Austria
Austria	Recruiting
Wein, Austria, 1090
Contact: Novartis 41613241111
Austria	Recruiting
Innsbruck, Austria, 6020
Contact: novartis 41613241111
Belgium
Belgium	Recruiting
Gent, Belgium, 9000
Contact: novartis 41613241111
Brazil
Brazil	Recruiting
Sao Paulo, Brazil, 04038-002
Contact: Novartis 41613241111
Czech Republic
Czech Republic	Recruiting
Praha, Czech Republic, 14021
Contact: Novartis 41613241111
France
France	Recruiting
Toulouse, France, 31055
Contact: Novartis 41613241111
France	Recruiting
Lille Cedex, France, 59037
Contact: novartis 41613241111
Italy
Italy	Recruiting
Milano, Italy, 20122
Contact: Novartis 41613241111
Italy	Recruiting
Milano, Italy, 20100
Contact: Novartis 41613241111
Netherlands
Netherlands	Recruiting
Rotterdam, Netherlands, 3000CA
Contact: Novartis 41613241111
Norway
Norway	Recruiting
Oslo, Norway, 0027
Contact: Novartis 41613241111
Spain
Spain	Recruiting
Barcelona, Spain, 08024
Contact: novartis 41613241111
Spain	Recruiting
Madrid, Spain, 28034
Contact: Novartis 41613241111

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CAEB071A2206
Study First Received:	July 19, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00504543 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Novartis:

Kidney transplant, AEB071

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors

Immunosuppressive Agents
Cyclosporins
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2009