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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00149981
First received: September 6, 2005
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Organ Transplantation
 Drug: everolimus
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

U.S. FDA Resources

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.


Estimated Enrollment: 1000
Study Start Date: August 2003
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: everolimus (RAD) Drug: everolimus
Everolimus

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149981

Locations
Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Hannover, Germany
Novartis Investigative Site
Heidelberg, Germany
Novartis Investigative Site
Kiel, Germany
Novartis Investigative Site
Regensburg, Germany
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
Study First Received: September 6, 2005
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on June 17, 2013