Clinical trial NCT01320358: Reliability, Safety and Usability of the Transplantation Sensor System Combined With Myfortic® in Adult Kidney Transplant Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Detection Accuracy
Patient Compliance
Keywords: Patient compliance
ECMPS-IEM
transplantation
renal maintenance
Proteus
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Proteus Digital Health, Inc.
name: Quintiles, Inc.
First posted: 2011-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess the reliability of the Raisin technology defined as accuracy and precision in detecting directly observed ingestion of ECMPS-IEM and Placebo-IEM.
timeFrame: 12 weeks
Secondary outcomes:
measure: 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.
timeFrame: 12 weeks
measure: the incidence and severity of adverse events observed during the utilization of the ECMPS-IEM and Proteus Personal Monitor (patch).
timeFrame: 12 weeks
measure: the satisfaction and usability of the TSS by patients
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonspital Aarau AG / Nephrologie
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern / Nephrology
city: Zurich
country: Switzerland
facility: Stadtspital Waid Zurich
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.