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.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00149981

Purpose

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

Condition	Intervention	Phase
Solid Organ Transplantation	Drug: Everolimus (RAD)	Phase IV

Drug Information available for: Everolimus

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Study Start Date:

January 2004

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both

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:

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

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

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CRAD001A2401
Study First Received:	September 6, 2005
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00149981
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Kidney, heart, lung, liver, islet transplant

Study placed in the following topic categories:

Everolimus

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009