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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00492869

Collaborator

(none)

124

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Drug: AEB071	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

May 1, 2008

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	USC Medical Center	Los Angeles	California	United States	90033
2	University of California San Diego	San Diego	California	United States	92103-8401
3	California Pacific Medical Center	San Francisco	California	United States	94115
4	UCSF	San Francisco	California	United States	94143
5	University of Colorado Health Science Center	Denver	Colorado	United States	80262
6	Lifelink, Inc.	Tampa	Florida	United States
7	U of Maryland Medical Center	Baltimore	Maryland	United States
8	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States
9	Brigham and Women's Hospital	Boston	Massachusetts	United States
10	University of Michigan Health System	Ann Arbor	Michigan	United States
11	Henry Ford Hospital Transplant Institute	Detroit	Michigan	United States
12	Saint Barnabas Medical Center	Livingston	New Jersey	United States	07039
13	Mount Sinai Medical Center	New York	New York	United States	10029
14	Comprehensive Transplant Clinic	New York	New York	United States
15	Duke University Medical Center	Durham	North Carolina	United States
16	University of Cincinnati, Dept of Internal Medicine	Cincinnati	Ohio	United States
17	University of Toledo Health Science Campus	Toledo	Ohio	United States
18	University of Pennsylvania Health System-Presbyterian Medical Center	Philadelphia	Pennsylvania	United States	19104
19	Baylor U Medical Center	Dallas	Texas	United States
20	University of Texas Medical Branch at Galveston	Galveston	Texas	United States	77555 - 0561
21	University of Utah	Salt Lake City	Utah	United States
22	U of Wisconsin Hospital Clinics	Madison	Wisconsin	United States
23	Medical College of Wisconsin	Milwaukee	Wisconsin	United States
24	CHU Erasme	Bruxelles		Belgium
25	UZ Gasthuisberg	Leuven		Belgium
26	Saint Joseph's Hospital	Hamilton	Ontario	Canada
27	Queen Elizabeth II	Halifax		Canada
28	Hopital Maisonneuve-Rosemont	Montreal Quebec		Canada
29	Klinikum der Humboldt Universitat Charite	Berlin		Germany
30	Universitaetsklinik Charité	Berlin		Germany
31	Medizinische Hochschule Hannover	Hannover		Germany
32	Univ.-Klinikum Heidelberg	Heidelberg		Germany
33	Staedt. Kliniken Koeln-Merheim	Koeln		Germany
34	Klinikum der Universitaet Regensburg	Regensburg		Germany
35	Fundacion Puigvert	Barcelona		Spain
36	Hospital Juan Canalejo	La Coruna		Spain
37	Enheten f Transpl och Leverkir, SU/Sahlgrenska	Goteborg		Sweden
38	Transplantationskirurgiska mottagningen, Akademiska Sjukhuse	Uppsala		Sweden
39	Addenbrookes Hospital	Cambridge		United Kingdom
40	Leicester General Hospital	Leicester		United Kingdom
41	Churchill Hospital	Oxford		United Kingdom