Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT00239018
Status:
COMPLETED
Last Update Posted:
2011-01-31
First Post:
2005-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients
Sponsor:
Novartis
Organization:
Study Overview
Official Title:
A Prospective, Open-label, Multicenter, Follow-up Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405FR01) to continue on the same treatment and to assess the long-term safety of EC-MPS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: