Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-27 @ 10:01 AM
Study NCT ID:
NCT00664066
Status:
TERMINATED
Last Update Posted:
2021-06-25
First Post:
2008-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment)
Sponsor:
Shire
Organization:
Study Overview
Official Title:
A Non-Interventional, Post-Authorisation Study to Assess Adverse Events and Drug Utilisation Among Chronic Kidney Disease Patients Treated With DYNEPO
Status:
TERMINATED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The termination of the study is not linked to a product recall or result of any safety signal. Rather it was sponsor's commercial decision to withdraw the MA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DELFT
Brief Summary:
This is a post-authorisation safety study to assess the incidence and severity of all pre-defined cardiovascular events in patients treated with DYNEPO, as well as to detect \& describe less common adverse drug reactions, and to summarise DYNEPO drug utilisation.
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?: