Reliability, Safety and Usability of the Transplantation Sensor System Combined With Myfortic® in Adult Kidney Transplant Patients

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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01320358

Enrollment

Registered

2011-03-22

Start date

2011-05-10

Completion date

2011-11-18

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Detection Accuracy, Patient Compliance

Keywords

Patient compliance, ECMPS-IEM, transplantation, renal maintenance, Proteus

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.

Interventions

DRUGECMPS-IEM

ECMPS-IEM

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients at least 6 months post-transplantation and in stable clinical condition * Treatment with ECMPS doses between 720 mg/day and 1440 mg/day or MMF doses between1000 mg/day and 2000 mg/day, divided in two equal doses 12 hours apart and with no dose titrations planned for the duration of the trial * Ability to independently take medication * Successfully ingest a Placebo-IEM capsule with no difficulty

Exclusion criteria

* Inability to use the mobile phone provided for use in the clinical trial * Any episodes of acute rejection in the previous 3 months * Presence of cognitive impairment * Active alcohol or drug abuse * History of dysphagia, or inflammatory bowel disease, or gastrointestinal conditions or surgery that has modified the normal luminal flow of the gastrointestinal tract (e.g. Whipple procedure, bariatric surgery or Roux-en-Y) * Known allergies, including history of skin reactions to patches, that could preclude safe participation in the study Other protocol-defined inclusion/

Design outcomes

Primary

Measure	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

Secondary

Measure	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).	12 weeks
the satisfaction and usability of the TSS by patients	12 weeks

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026