Reliability, Safety and Usability of the Transplantation Sensor System Combined With Myfortic® in Adult Kidney Transplant Patients
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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.
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
Actual Study Start Date :
May 10, 2011
Actual Primary Completion Date :
November 18, 2011
Actual Study Completion Date :
November 18, 2011
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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