A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation

NCT00149981 | Unknown

• 2 other identifiers: CRAD001A24012004-001473-25
• Study Type: expanded_access
• Target: N/A
• Locations: 19 countries
• Sites: 153

Brief Summary

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

Conditions

Organ Transplantation

Keywords

Kidney, heart, lung, liver, pancreas

Interventions

everolimus (RAD) DRUG

Everolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (153)

Novartis Investigative Site

Birmingham, Alabama, 35233, United States

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Novartis Investigative Site

Birmingham, Alabama, 35294-0006, United States

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Novartis Investigative Site

Mobile, Alabama, 36617, United States

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Novartis Investigative Site

Los Angeles, California, 90024, United States

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Los Angeles, California, 90027, United States

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Los Angeles, California, 90048, United States

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Los Angeles, California, 90057, United States

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Los Angeles, California, 90095, United States

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San Diego, California, 92103-8745, United States

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San Francisco, California, 94115, United States

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Stanford, California, 94304, United States

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Aurora, Colorado, 80045, United States

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Denver, Colorado, 80218, United States

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New Haven, Connecticut, 06510, United States

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Gainesville, Florida, 32610-0277, United States

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Tampa, Florida, 33606, United States

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Atlanta, Georgia, 30309, United States

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Atlanta, Georgia, 30322, United States

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Augusta, Georgia, 30912-3140, United States

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Chicago, Illinois, 60612, United States

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Chicago, Illinois, 60637, United States

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Maywood, Illinois, 60153, United States

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Des Moines, Iowa, 50309, United States

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Lexington, Kentucky, 40536-0293, United States

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New Orleans, Louisiana, 70112, United States

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New Orleans, Louisiana, 70121, United States

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Shreveport, Louisiana, 71103, United States

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Baltimore, Maryland, 21287, United States

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Boston, Massachusetts, 02111, United States

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Worcester, Massachusetts, 01655, United States

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Ann Arbor, Michigan, 48109-0331, United States

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St Louis, Missouri, 63104-1314, United States

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St Louis, Missouri, 63110, United States

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Omaha, Nebraska, 68198, United States

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Livingston, New Jersey, 07039, United States

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New Brunswick, New Jersey, 08901, United States

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Albany, New York, 12208, United States

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Buffalo, New York, 14203, United States

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New York, New York, 10032, United States

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The Bronx, New York, 10467, United States

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Valhalla, New York, 10595, United States

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Durham, North Carolina, 27710, United States

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Greenville, North Carolina, 27834, United States

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Winston-Salem, North Carolina, 27157, United States

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Fargo, North Dakota, 58122, United States

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Cleveland, Ohio, 44106-5048, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43205-2696, United States

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Columbus, Ohio, 43210, United States

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Philadelphia, Pennsylvania, 19102 2293, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19140, United States

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Providence, Rhode Island, 02903, United States

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Charleston, South Carolina, 29403, United States

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Charleston, South Carolina, 29425, United States

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Nashville, Tennessee, 37212, United States

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Dallas, Texas, 75246, United States

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Galveston, Texas, 77555-0144, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Murray, Utah, 84157, United States

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Salt Lake City, Utah, 84132, United States

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Charlottesville, Virginia, 22908, United States

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Norfolk, Virginia, 23507, United States

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Richmond, Virginia, 23284, United States

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Charleston, West Virginia, 25301, United States

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Madison, Wisconsin, 53792, United States

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Milwaukee, Wisconsin, 53215, United States

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Camperdown, New South Wales, 2050, Australia

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Darlinghurst, New South Wales, 2010, Australia

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Woolloongabba, Queensland, 4102, Australia

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Clayton, Victoria, 3168, Australia

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Parkville, Victoria, 3052, Australia

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Brussels, 1070, Belgium

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Brussels, 1200, Belgium

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Leuven, 3000, Belgium

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Belo Horizonte, Minas Gerais, 30110-934, Brazil

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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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São Paulo, São Paulo, 04023-900, Brazil

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São Paulo, São Paulo, 05403-000, Brazil

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Edmonton, Alberta, T6G 2B7, Canada

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Vancouver, British Columbia, V6Z 1Y6, Canada

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Halifax, Nova Scotia, B3H 2Y6, Canada

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Hamilton, Ontario, L8N 4A6, Canada

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London, Ontario, N6A 5A5, Canada

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Toronto, Ontario, M5C 2T2, Canada

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Toronto, Ontario, M5G 2C4, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Sainte-Foy, Quebec, G1V 4G5, Canada

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Saskatoon, Saskatchewan, S7N 0W8, Canada

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Brno, 656 91, Czechia

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Hradec Králové, 505 00, Czechia

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Ostrava-Poruba, 708 52, Czechia

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Prague, 140 21, Czechia

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Brest, 29200, France

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Créteil, 94010, France

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Grenoble, 38000, France

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Le Plessis-Robinson, 92350, France

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Lyon, 69437, France

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Monpellier, 34295, France

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Nantes, 44035, France

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Paris, 75010, France

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Paris, 75651, France

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Saint-Etienne, 42055, France

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Toulouse, 31054, France

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Tours, 37044, France

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Vandœuvre-lès-Nancy, 54511, France

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Villejuif, 94800, France

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Regensburg, Bavaria, 93053, Germany

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Essen, 45147, Germany

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Hamburg, 20246, Germany

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Hanover, 30625, Germany

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Heidelberg, 69120, Germany

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Kiel, 24105, Germany

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Milan, MI, 20122, Italy

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Milan, MI, 20162, Italy

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Padua, PD, 35128, Italy

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Perugia, PG, 06100, Italy

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Pisa, PI, 56124, Italy

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Parma, PR, 43100, Italy

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Pavia, PV, 27100, Italy

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Roma, RM, 00168, Italy

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Siena, SI, 53100, Italy

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Sassari, SS, 07100, Italy

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Vicenza, VI, 36100, Italy

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Auckland, 1001, New Zealand

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Oslo, 0424, Norway

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Warsaw, 02-006, Poland

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San Juan, 00936-6528, Puerto Rico

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Moscow, 115446, Russia

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Johannesburg, 2198, South Africa

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Córdoba, Andalusia, 14004, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Santander, Cantabria, 39008, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

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Barcelona, Catalonia, 08036, Spain

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Valencia, Valencia, 46026, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Madrid, 28034, Spain

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Madrid, 28041, Spain

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Madrid, 28222, Spain

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Bern, 3010, Switzerland

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Zurich, 8091, Switzerland

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Taichung, Taiwan ROC, 40201, Taiwan

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Tainan, Taiwan ROC, 70403, Taiwan

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Taichung, 40705, Taiwan

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Taipei, 10002, Taiwan

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Taoyuan District, 33305, Taiwan

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London, E1 1BB, United Kingdom

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London, SE1 9RT, United Kingdom

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Manchester, M23 9LT, United Kingdom

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Salford, M6 8HD, United Kingdom

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MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Last Updated: September 9, 2019

Record last verified: 2019-09

Locations

AU (5); BE (3); ES (10); PR (1); CH (2); NO (1); NZ (1); GB (4); TW (5); DE (6); RU (1); IT (11); CA (11); ZA (1); FR (14); US (68); PL (1); CZ (4); BR (4)