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

Phase 2

Completed

• Conditions: Detection Accuracy; Patient Compliance
• Interventions: Drug: ECMPS-IEM

• Registration Number: NCT01320358
• Lead Sponsor: Novartis Pharmaceuticals

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

Not available

Study Timeline

• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Study Start: 2011-05-10
• Primary Completion: 2011-11-18
• Study Completion: 2011-11-18
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ECMPS-IEM	ECMPS-IEM	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Inselspital Bern / Nephrology; 🇨🇭 Bern, Switzerland

Kantonspital Aarau AG / Nephrologie; 🇨🇭 Aarau, Switzerland

University Hospital Basel; 🇨🇭 Basel, Switzerland

Stadtspital Waid Zurich; 🇨🇭 Zurich, Switzerland

University Hospital Zurich; 🇨🇭 Zurich, Switzerland