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

This study has been completed.
Sponsor:
Collaborators:
Proteus Digital Health, Inc.
Quintiles
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01320358
First received: March 21, 2011
Last updated: September 20, 2012
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Detection Accuracy
Patient Compliance
 Drug: ECMPS-IEM
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • the incidence and severity of adverse events observed during the utilization of the ECMPS-IEM and Proteus Personal Monitor (patch). [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • the satisfaction and usability of the TSS by patients [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ECMPS-IEM Drug: ECMPS-IEM
ECMPS-IEM

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320358

Locations
Switzerland
Kantonspital Aarau AG / Nephrologie
Aarau, Switzerland, 5001
University Hospital Basel
Basel, Switzerland, 4000
Inselspital Bern / Nephrology
Bern, Switzerland, 3010
University Hospital Zurich
Zurich, Switzerland, 8091
Stadtspital Waid Zurich
Zurich, Switzerland, 8037
Sponsors and Collaborators
Novartis Pharmaceuticals
Proteus Digital Health, Inc.
Quintiles
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01320358     History of Changes
Other Study ID Numbers: CPRO400A2201
Study First Received: March 21, 2011
Last Updated: September 20, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Novartis:
Patient compliance
ECMPS-IEM
transplantation
renal maintenance
Proteus

Additional relevant MeSH terms:
Mycophenolate mofetil
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013