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Completed

NCT Number: NCT01320358

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

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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Key information

Conditions

Detection Accuracy Bacterial Infections Bacterial Infections and Mycoses Behavior Enterobacteriaceae Infections Gram-Negative Bacterial Infections Health Behavior Infections Patient Acceptance of Health Care Patient Compliance Proteus Infections Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kantonspital Aarau AG / Nephrologie, Aarau, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECMPS-IEM

Drug

ECMPS-IEM

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. the incidence and severity of adverse events observed during the utilization of the ECMPS-IEM and Proteus Personal Monitor (patch).

    Time frame: 12 weeks

  3. the satisfaction and usability of the TSS by patients

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Collaborators

  • Proteus Digital Health, Inc.
  • Quintiles, Inc.

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 22, 2011
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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