Clinical trial NCT00492869: Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Kidney Transplantation
Keywords: kidney transplantation
rejection
AEB071
tacrolimus
mycophenolic
basiliximab
immunosuppression
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: 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 outcomes:
measure: Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Medical Center
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Denver
country: United States
facility: University of Colorado Health Science Center
state: Colorado
city: Tampa
country: United States
facility: Lifelink, Inc.
state: Florida
city: Baltimore
country: United States
facility: U of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital Transplant Institute
state: Michigan
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Comprehensive Transplant Clinic
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati, Dept of Internal Medicine
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Health Science Campus
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System-Presbyterian Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor U Medical Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Madison
country: United States
facility: U of Wisconsin Hospital Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Bruxelles
country: Belgium
facility: CHU Erasme
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Hamilton
country: Canada
facility: Saint Joseph's Hospital
state: Ontario
city: Halifax
country: Canada
facility: Queen Elizabeth II
city: Montreal Quebec
country: Canada
facility: Hopital Maisonneuve-Rosemont
city: Berlin
country: Germany
facility: Klinikum der Humboldt Universitat Charite
city: Berlin
country: Germany
facility: Universitaetsklinik Charité
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Univ.-Klinikum Heidelberg
city: Koeln
country: Germany
facility: Staedt. Kliniken Koeln-Merheim
city: Regensburg
country: Germany
facility: Klinikum der Universitaet Regensburg
city: Barcelona
country: Spain
facility: Fundacion Puigvert
city: La Coruna
country: Spain
facility: Hospital Juan Canalejo
city: Goteborg
country: Sweden
facility: Enheten f Transpl och Leverkir, SU/Sahlgrenska
city: Uppsala
country: Sweden
facility: Transplantationskirurgiska mottagningen, Akademiska Sjukhuse
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Friman S, Arns W, Nashan B, Vincenti F, Banas B, Budde K, Cibrik D, Chan L, Klempnauer J, Mulgaonkar S, Nicholson M, Wahlberg J, Wissing KM, Abrams K, Witte S, Woodle ES. Sotrastaurin, a novel small molecule inhibiting protein-kinase C: randomized phase II study in renal transplant recipients. Am J Transplant. 2011 Jul;11(7):1444-55. doi: 10.1111/j.1600-6143.2011.03538.x. Epub 2011 May 12.