Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: December 17, 2004
Last updated: November 1, 2011
Last verified: November 2011
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.
Secondary Outcome Measures:
- Safety/tolerability based on adverse event reporting.
- BPAR, graft loss, death and study discontinuation, within 6 and 12 months post transplantation.
- Efficacy parameters between the 3 treatment groups within 6 and 12 months post-transplantation.
|Study Start Date:||November 2003|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099749
|United States, Illinois|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|SIU School of Medicine|
|Springfield, Illinois, United States, 62781|
|United States, New Jersey|
|St. Barnabas Medical Center|
|Livingston, New Jersey, United States, 07039|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
Sponsors and Collaborators