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

Novartis

Status and phase

Completed

Phase 2

Conditions

Detection Accuracy

Patient Compliance

Treatments

Drug: ECMPS-IEM

Study type

Interventional

Funder types

Industry

Identifiers

NCT01320358

CPRO400A2201

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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