Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-25 @ 4:11 PM
Study NCT ID:
NCT01284257
Status:
WITHDRAWN
Last Update Posted:
2017-02-27
First Post:
2011-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Registry Study of Renal Transplant Patients
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase IV, Non-interventional, Multi-center, Open-label, Prospective, Observational Study of the Safety, Effectiveness, Tolerability and Compliance of Immunosuppressive Regimens Using Mycophenolic Acid to Treat de Novo Renal Transplant Patients in Routine Clinical Practice
Status:
WITHDRAWN
Status Verified Date:
2017-02
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:
MORE registry
Brief Summary:
The MORE Observational Study follows real-world renal transplant patients with the data resolution of a monitored, prospective clinical trial for 5 years. In addition to capturing detailed clinical data, the study describes recent important changes in surveillance testing and drug therapy and relates these changes to short and long-term outcomes. Also, the study measures patient compliance over time and details the rationale for modifications of MPA dosing in maintenance and regimen changes after episodes of AR. The MORE study will provide information on era changes in transplant practices and their impact on clinical outcome, new insights on optimizing regimens for discrete patient subsets and new perspectives on the optimal use of MPA therapy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: