Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Novartis Pharmaceuticals |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00267189 |
The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related renal impairment, while maintaining efficacy.
Condition | Intervention | Phase |
---|---|---|
Liver Transplantation |
Drug: Everolimus (RAD001) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 6-Month, Multicenter, Randomized, Open-Label Study of Safety and Efficacy of Everolimus-Based Regimen Versus Calcineurin Inhibitor (CNI)-Based Regimen in Maintenance Liver Transplant Recipients |
Study Start Date: | November 2005 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Inclusion criteria
Exclusion criteria
Contact: Novarts Pharmaceuticals | 41 61 324 11 11 |
Germany | |
Novartis Investigational Site | Recruiting |
Germany, Germany | |
Contact: Novartis Pharmaceuticals 41613241111 | |
Switzerland | |
Novartis Investigative Site | Recruiting |
Basel, Switzerland | |
Contact: Novartis Pharmaceuticals 41 61 324 11 11 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CRAD001H2401 |
Study First Received: | December 19, 2005 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00267189 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Liver transplantation, everolimus, calcineurin inhibitor, renal function |
Everolimus Renal Insufficiency |
Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |