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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:
ClinicalTrials.gov Identifier:
NCT01320358
First Posted: March 22, 2011
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Proteus Digital Health, Inc.
Quintiles, Inc.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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: None (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:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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 ]

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 ]
  • the incidence and severity of adverse events observed during the utilization of the ECMPS-IEM and Proteus Personal Monitor (patch). [ Time Frame: 12 weeks ]
  • the satisfaction and usability of the TSS by patients [ Time Frame: 12 weeks ]

Estimated Enrollment: 30
Actual Study Start Date: May 10, 2011
Study Completion Date: November 18, 2011
Primary Completion Date: November 18, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ECMPS-IEM Drug: ECMPS-IEM
ECMPS-IEM

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320358


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

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01320358     History of Changes
Other Study ID Numbers: CPRO400A2201
First Submitted: March 21, 2011
First Posted: March 22, 2011
Last Update Posted: February 23, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action