Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00492869

Purpose

Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.

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

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Corticosteroids Tacrolimus anhydrous Basiliximab

U.S. FDA Resources

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

Further study details as provided by Novartis:

Primary Outcome Measures:

Efficacy will be defined using a composite efficacy failure end point (treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up) between treatment and control arms

Secondary Outcome Measures:

Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies

Estimated Enrollment:	258
Study Start Date:	May 2007
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:

Male and female patients of any race 18 years or older
Adult recipients of kidney transplant from a deceased or living donor
Recipients of a functioning kidney within 24 hours post transplant

Exclusion:

Need for medication prohibited by the protocol
Patients or donors infected with Hepatitis B,C or HIV
Patients with a history of cancer within last 5 years
Patients with history of significant cardiac disorder
Patients of high-risk immunological status

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492869

Show 41 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CAEB0712207
Study First Received:	June 26, 2007
Last Updated:	March 18, 2008
ClinicalTrials.gov Identifier:	NCT00492869
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

kidney transplantation
rejection
AEB071
tacrolimus

mycophenolic
basiliximab
immunosuppression

Study placed in the following topic categories:

Basiliximab
Signs and Symptoms
Mycophenolate mofetil
Tacrolimus

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009