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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
ECMPS-IEM
Kantonspital Aarau AG / Nephrologie
Aarau, Switzerland
University Hospital Basel
Basel, Switzerland
Inselspital Bern / Nephrology
Bern, Switzerland
Stadtspital Waid Zurich
Zurich, Switzerland
To assess the reliability of the Raisin technology defined as accuracy and precision in detecting directly observed ingestion of ECMPS-IEM and Placebo-IEM.
Time frame: 12 weeks
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.
Time frame: 12 weeks
the incidence and severity of adverse events observed during the utilization of the ECMPS-IEM and Proteus Personal Monitor (patch).
Time frame: 12 weeks
the satisfaction and usability of the TSS by patients
Time frame: 12 weeks
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University Hospital Zurich
Zurich, Switzerland