drugset / Trial / NCT01320358
Reliability, Safety and Usability of the Transplantation Sensor System Combined With Myfortic® in Adult Kidney Transplant Patients
Phase 2
Completed
30 enrolled
Novartis Pharmaceuticals
Proteus Digital Health, Inc. · collabQuintiles, Inc. · collab
NaSingle-groupOpen-labelSupportive care
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.
Timeline
- Start
- 2011-05-10
- Primary completion
- 2011-11-18
- Completion
- 2011-11-18
Publications
- Background Fine RN, Becker Y, De Geest S, Eisen H, Ettenger R, Evans R, Rudow DL, McKay D, Neu A, Nevins T, Reyes J, Wray J, Dobbels F. Nonadherence consensus conference summary report. Am J Transplant. 2009 Jan;9(1):35-41. doi: 10.1111/j.1600-6143.2008.02495.x.
- Results Eisenberger U, Wuthrich RP, Bock A, Ambuhl P, Steiger J, Intondi A, Kuranoff S, Maier T, Green D, DiCarlo L, Feutren G, De Geest S. Medication adherence assessment: high accuracy of the new Ingestible Sensor System in kidney transplants. Transplantation. 2013 Aug 15;96(3):245-50. doi: 10.1097/TP.0b013e31829b7571.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Mycophenolate Sodium | Unknown | 360 mg | Oral |
Indications
No indication recorded.