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

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ClinicalTrials.gov Identifier: NCT00149981
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Organ Transplantation Drug: everolimus (RAD) Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 1025 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation
Study Start Date : August 2003
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: everolimus (RAD)
Everolimus according to local practice
Drug: everolimus (RAD)
Everolimus



Primary Outcome Measures :
  1. Adverse event reporting [ Time Frame: up to the end of study ]
    To facilitate the management of patients on maintenance immunosuppression therapy who are completing everolimus trials. To provide everolimus maintenance therapy through this access program.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149981


  Show 153 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00149981     History of Changes
Other Study ID Numbers: CRAD001A2401
2004-001473-25
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Kidney, heart, lung, liver, pancreas

Additional relevant MeSH terms:
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents