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

September 6, 2019 updated by: Novartis Pharmaceuticals
Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Novartis Investigative Site
      • Darlinghurst, New South Wales, Australia, 2010
        • Novartis Investigative Site
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Novartis Investigative Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Novartis Investigative Site
      • Parkville, Victoria, Australia, 3052
        • Novartis Investigative Site
  • Belgium
      • Bruxelles, Belgium, 1200
        • Novartis Investigative Site
      • Bruxelles, Belgium, 1070
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
  • Brazil
    • MG
      • Belo Horizonte, MG, Brazil, 30110-934
        • Novartis Investigative Site
    • RS
      • Porto Alegre, RS, Brazil, 90020-090
        • Novartis Investigative Site
    • SP
      • Sao Paulo, SP, Brazil, 04023-900
        • Novartis Investigative Site
      • São Paulo, SP, Brazil, 05403-000
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y6
        • Novartis Investigative Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Novartis Investigative Site
      • London, Ontario, Canada, N6A 5A5
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5C 2T2
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H3A 1A1
        • Novartis Investigative Site
      • Sainte Foy, Quebec, Canada, G1V 4G5
        • Novartis Investigative Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Novartis Investigative Site
  • Czechia
      • Brno, Czechia, 656 91
        • Novartis Investigative Site
      • Hradec Kralove, Czechia, 505 00
        • Novartis Investigative Site
      • Ostrava-Poruba, Czechia, 708 52
        • Novartis Investigative Site
      • Prague 4, Czechia, 140 21
        • Novartis Investigative Site
  • France
      • Brest, France, 29200
        • Novartis Investigative Site
      • Créteil, France, 94010
        • Novartis Investigative Site
      • Grenoble CEDEX, France, 38000
        • Novartis Investigative Site
      • Le Plessis Robinson, France, 92350
        • Novartis Investigative Site
      • Lyon, France, 69437
        • Novartis Investigative Site
      • Monpellier, France, 34295
        • Novartis Investigative Site
      • Nantes, France, 44035
        • Novartis Investigative Site
      • Paris, France, 75010
        • Novartis Investigative Site
      • Paris, France, 75651
        • Novartis Investigative Site
      • Saint-Etienne, France, 42055
        • Novartis Investigative Site
      • Toulouse, France, 31054
        • Novartis Investigative Site
      • Tours, France, 37044
        • Novartis Investigative Site
      • Vandoeuvre-Les-Nancy, France, 54511
        • Novartis Investigative Site
      • Villejuif, France, 94800
        • Novartis Investigative Site
  • Germany
      • Essen, Germany, 45147
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Novartis Investigative Site
      • Kiel, Germany, 24105
        • Novartis Investigative Site
    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • Novartis Investigative Site
  • Italy
    • MI
      • Milano, MI, Italy, 20162
        • Novartis Investigative Site
      • Milano, MI, Italy, 20122
        • Novartis Investigative Site
    • PD
      • Padova, PD, Italy, 35128
        • Novartis Investigative Site
    • PG
      • Perugia, PG, Italy, 06100
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italy, 56124
        • Novartis Investigative Site
    • PR
      • Parma, PR, Italy, 43100
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00168
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italy, 53100
        • Novartis Investigative Site
    • SS
      • Sassari, SS, Italy, 07100
        • Novartis Investigative Site
    • VI
      • Vicenza, VI, Italy, 36100
        • Novartis Investigative Site
  • New Zealand
      • Auckland, New Zealand, 1001
        • Novartis Investigative Site
  • Norway
      • Oslo, Norway, 0424
        • Novartis Investigative Site
  • Poland
      • Warszawa, Poland, 02-006
        • Novartis Investigative Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00936-6528
        • Novartis Investigative Site
  • Russian Federation
      • Moscow, Russian Federation, 115446
        • Novartis Investigative Site
  • South Africa
      • Johannesburg, South Africa, 2198
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28041
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Novartis Investigative Site
      • Madrid, Spain, 28222
        • Novartis Investigative Site
    • Andalucia
      • Cordoba, Andalucia, Spain, 14004
        • Novartis Investigative Site
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Novartis Investigative Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08036
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46026
        • Novartis Investigative Site
    • Vizcaya
      • Baracaldo, Vizcaya, Spain, 48903
        • Novartis Investigative Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Novartis Investigative Site
      • Zuerich, Switzerland, 8091
        • Novartis Investigative Site
  • Taiwan
      • Taichung, Taiwan, 40705
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Novartis Investigative Site
    • Taiwan ROC
      • Taichung, Taiwan ROC, Taiwan, 40201
        • Novartis Investigative Site
      • Tainan, Taiwan ROC, Taiwan, 70403
        • Novartis Investigative Site
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Novartis Investigative Site
      • London, United Kingdom, E1 1BB
        • Novartis Investigative Site
      • Manchester, United Kingdom, M23 9LT
        • Novartis Investigative Site
      • Salford, United Kingdom, M6 8HD
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Novartis Investigative Site
      • Birmingham, Alabama, United States, 35294-0006
        • Novartis Investigative Site
      • Mobile, Alabama, United States, 36617
        • Novartis Investigative Site
    • California
      • Los Angeles, California, United States, 90048
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90027
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90095
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90024
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90057
        • Novartis Investigative Site
      • San Diego, California, United States, 92103-8745
        • Novartis Investigative Site
      • San Francisco, California, United States, 94115
        • Novartis Investigative Site
      • Stanford, California, United States, 94304
        • Novartis Investigative Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Novartis Investigative Site
      • Denver, Colorado, United States, 80218
        • Novartis Investigative Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Novartis Investigative Site
    • Florida
      • Gainesville, Florida, United States, 32610-0277
        • Novartis Investigative Site
      • Tampa, Florida, United States, 33606
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Novartis Investigative Site
      • Atlanta, Georgia, United States, 30309
        • Novartis Investigative Site
      • Augusta, Georgia, United States, 30912-3140
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Novartis Investigative Site
      • Chicago, Illinois, United States, 60637
        • Novartis Investigative Site
      • Maywood, Illinois, United States, 60153
        • Novartis Investigative Site
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Novartis Investigative Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0293
        • Novartis Investigative Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Novartis Investigative Site
      • New Orleans, Louisiana, United States, 70121
        • Novartis Investigative Site
      • Shreveport, Louisiana, United States, 71103
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Novartis Investigative Site
      • Worcester, Massachusetts, United States, 01655
        • Novartis Investigative Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0331
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Novartis Investigative Site
      • Saint Louis, Missouri, United States, 63104-1314
        • Novartis Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Novartis Investigative Site
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Novartis Investigative Site
      • New Brunswick, New Jersey, United States, 08901
        • Novartis Investigative Site
    • New York
      • Albany, New York, United States, 12208
        • Novartis Investigative Site
      • Bronx, New York, United States, 10467
        • Novartis Investigative Site
      • Buffalo, New York, United States, 14203
        • Novartis Investigative Site
      • New York, New York, United States, 10032
        • Novartis Investigative Site
      • Valhalla, New York, United States, 10595
        • Novartis Investigative Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Novartis Investigative Site
      • Greenville, North Carolina, United States, 27834
        • Novartis Investigative Site
      • Winston-Salem, North Carolina, United States, 27157
        • Novartis Investigative Site
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Novartis Investigative Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Novartis Investigative Site
      • Cleveland, Ohio, United States, 44106-5048
        • Novartis Investigative Site
      • Columbus, Ohio, United States, 43210
        • Novartis Investigative Site
      • Columbus, Ohio, United States, 43205-2696
        • Novartis Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, United States, 19102 2293
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, United States, 19140
        • Novartis Investigative Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Novartis Investigative Site
      • Charleston, South Carolina, United States, 29403
        • Novartis Investigative Site
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Novartis Investigative Site
      • Galveston, Texas, United States, 77555-0144
        • Novartis Investigative Site
      • Houston, Texas, United States, 77030
        • Novartis Investigative Site
      • San Antonio, Texas, United States, 78229
        • Novartis Investigative Site
    • Utah
      • Murray, Utah, United States, 84157
        • Novartis Investigative Site
      • Salt Lake City, Utah, United States, 84132
        • Novartis Investigative Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Novartis Investigative Site
      • Norfolk, Virginia, United States, 23507
        • Novartis Investigative Site
      • Richmond, Virginia, United States, 23284
        • Novartis Investigative Site
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Novartis Investigative Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Novartis Investigative Site
      • Milwaukee, Wisconsin, United States, 53215
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Actual)

September 9, 2019

Last Update Submitted That Met QC Criteria

September 6, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001A2401
  • 2004-001473-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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