Viewing Study NCT01011205


Ignite Creation Date: 2025-12-25 @ 3:18 AM
Ignite Modification Date: 2025-12-31 @ 6:30 PM
Study NCT ID: NCT01011205
Status: COMPLETED
Last Update Posted: 2024-11-01
First Post: 2009-11-10
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation
Sponsor: Astellas Pharma Inc
Organization:

Study Overview

Official Title: A Multicenter, Three Arm, Randomized, Open Label Clinical Study to Compare Renal Function in Liver Transplant Recipients Receiving an Immunosuppressive Regimen of Advagraf (Immediately or Delayed Post-transplant) and MMF With or Without a Monoclonal Anti-IL2R Antibody (Basiliximab)
Status: COMPLETED
Status Verified Date: 2024-10
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: DIAMOND
Brief Summary: Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.
Detailed Description: None

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
2008-002231-32 EUDRACT_NUMBER EudraCT View
2010-021075-89 EUDRACT_NUMBER None View