Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-29 @ 1:55 AM
Study NCT ID:
NCT01320358
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2011-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability, Safety and Usability of the Transplantation Sensor System Combined With Myfortic® in Adult Kidney Transplant Patients
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A 3-month, Exploratory, Non-randomized, Multi-center, Open Label Study to Evaluate the Reliability, Safety and Usability of the Transplantation Sensor System Combined With Myfortic® in Adult Kidney Transplant Patients
Status:
COMPLETED
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:
None
Brief Summary:
The main purpose of this exploratory trial is to evaluate the reliability, safety and usability of the Transplantation Sensor System when the Ingestible Event Marker (IEM) is given in combination with ECMPS 360 mg tablets in adult renal transplant recipients.
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?: