Organ Transplantation
Conditions
Keywords
Kidney, heart, lung, liver, pancreas
Brief summary
Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties
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.
Interventions
DRUGeverolimus (RAD)
Everolimus
Sponsors
Novartis Pharmaceuticals
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Countries
Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Italy, New Zealand, Norway, Poland, Puerto Rico, Russia, South Africa, Spain, Switzerland, Taiwan, United Kingdom, United States
Outcome results
None listed