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

• Status: Completed
• Trial end date: 2011-11-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Collaborators: Proteus Digital Health, Inc.; Quintiles, Inc.
• Treatments: Mycophenolate mofetil

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