Clinical trial NCT00149981: A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation
Official title: A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Organ Transplantation
Keywords: Kidney, heart, lung, liver, pancreas
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties

Detailed description: This is a treatment protocol designed only to provide access to everolimus (RAD) for maintenance immunosuppression. The objectives are to facilitate the management of patients on maintenance immunosuppression therapy who are completing everolimus trials,

* To provide everolimus maintenance therapy through this access program and
* To collect and review safety data for up to 120 months or until the project has been discontinued whichever comes first.
* To collect and review safety data for up to 120 months or when Certican is commercially available in the given indication and reimbursed by appropriate payors or the project has been discontinued whichever comes first.

Eligibility criteria: Inclusion Criteria:

* Male or female recipients of solid organ transplants
* Subject is currently enrolled in an everolimus (RAD) trial sponsored by Novartis
* Currently on investigational drug everolimus (RAD) therapy

Exclusion Criteria:

* Inability or unwillingness to comply with immunosuppressive regimen.
* Pregnancy.
* History of acute organ rejection within the last 3 months.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Mobile
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: San Francisco
country: United States
facility: Novartis Investigative Site
state: California
city: Stanford
country: United States
facility: Novartis Investigative Site
state: California
city: Aurora
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: New Haven
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Gainesville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Tampa
country: United States
facility: Novartis Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Augusta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Maywood
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Des Moines
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Lexington
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: New Orleans
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: New Orleans
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Shreveport
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Worcester
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Livingston
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: New Brunswick
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Albany
country: United States
facility: Novartis Investigative Site
state: New York
city: Bronx
country: United States
facility: Novartis Investigative Site
state: New York
city: Buffalo
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Valhalla
country: United States
facility: Novartis Investigative Site
state: New York
city: Durham
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Greenville
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Fargo
country: United States
facility: Novartis Investigative Site
state: North Dakota
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Providence
country: United States
facility: Novartis Investigative Site
state: Rhode Island
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Galveston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Murray
country: United States
facility: Novartis Investigative Site
state: Utah
city: Salt Lake City
country: United States
facility: Novartis Investigative Site
state: Utah
city: Charlottesville
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Norfolk
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Charleston
country: United States
facility: Novartis Investigative Site
state: West Virginia
city: Madison
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Camperdown
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Darlinghurst
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Woolloongabba
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Clayton
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Belo Horizonte
country: Brazil
facility: Novartis Investigative Site
state: MG
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sainte Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Saskatoon
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Brno
country: Czechia
facility: Novartis Investigative Site
city: Hradec Kralove
country: Czechia
facility: Novartis Investigative Site
city: Ostrava-Poruba
country: Czechia
facility: Novartis Investigative Site
city: Prague 4
country: Czechia
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: Créteil
country: France
facility: Novartis Investigative Site
city: Grenoble CEDEX
country: France
facility: Novartis Investigative Site
city: Le Plessis Robinson
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Monpellier
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Saint-Etienne
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Tours
country: France
facility: Novartis Investigative Site
city: Vandoeuvre-Les-Nancy
country: France
facility: Novartis Investigative Site
city: Villejuif
country: France
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Perugia
country: Italy
facility: Novartis Investigative Site
state: PG
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Parma
country: Italy
facility: Novartis Investigative Site
state: PR
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Siena
country: Italy
facility: Novartis Investigative Site
state: SI
city: Sassari
country: Italy
facility: Novartis Investigative Site
state: SS
city: Vicenza
country: Italy
facility: Novartis Investigative Site
state: VI
city: Auckland
country: New Zealand
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: San Juan
country: Puerto Rico
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Johannesburg
country: South Africa
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Santander
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Baracaldo
country: Spain
facility: Novartis Investigative Site
state: Vizcaya
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
state: Taiwan ROC
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
state: Taiwan ROC
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taoyuan
country: Taiwan
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Salford
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: