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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00149981
First received: September 6, 2005
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention Phase
Organ Transplantation
Drug: everolimus (RAD)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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


Enrollment: 1025
Study Start Date: August 2003
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: everolimus (RAD)
Everolimus according to local practice
Drug: everolimus (RAD)
Everolimus

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149981

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00149981     History of Changes
Other Study ID Numbers: CRAD001A2401, 2004-001473-25
Study First Received: September 6, 2005
Last Updated: November 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Kidney, heart, lung, liver, pancreas

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

ClinicalTrials.gov processed this record on November 27, 2014