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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
First received: September 6, 2005
Last updated: March 4, 2014
Last verified: March 2014

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

Condition Intervention Phase
Organ Transplantation
Drug: everolimus
Phase 4

Novartis Pharmaceuticals has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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:

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


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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
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: March 4, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
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 October 22, 2014