Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
This study has been completed.
Information provided by:
First received: December 3, 2004
Last updated: June 15, 2011
Last verified: June 2011
The purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican) administered to pediatric renal transplant recipients, and to provide additional safety data.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter Trial of the Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections.
Secondary Outcome Measures:
- Efficacy at 6 and 12 Months as measured by rejection, graft loss, death and loss to follow up.
|Study Start Date:||June 2000|
|Study Completion Date:||March 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098241
|United States, Ohio|
|Columbus Children's Hospital|
|Columbus, Ohio, United States, 43205-2696|
|Dienst Pediatrie UZ Gasthuisberg, Herestraat 49|
|Leuven, Belgium, 3000|
Sponsors and Collaborators