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| Name | Class |
|---|---|
| Proteus Digital Health, Inc. | INDUSTRY |
| Quintiles, Inc. | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECMPS-IEM | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECMPS-IEM | Drug | ECMPS-IEM |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the reliability of the Raisin technology defined as accuracy and precision in detecting directly observed ingestion of ECMPS-IEM and Placebo-IEM. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the adherence (taking and scheduling) to prescribed ECMPS-IEM schedule with and without active feedback for two consecutive periods of 8 and 4 weeks each. | 12 weeks | |
| the incidence and severity of adverse events observed during the utilization of the ECMPS-IEM and Proteus Personal Monitor (patch). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonspital Aarau AG / Nephrologie | Aarau | 5001 | Switzerland | |||
| University Hospital Basel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19133930 | 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. | |
| 23823651 | Result | 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. |
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| 12 weeks |
| the satisfaction and usability of the TSS by patients | 12 weeks |
| Basel |
| 4000 |
| Switzerland |
| Inselspital Bern / Nephrology | Bern | 3010 | Switzerland |
| Stadtspital Waid Zurich | Zurich | 8037 | Switzerland |
| University Hospital Zurich | Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D011512 | Proteus Infections |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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