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

March 21, 2011
September 20, 2012
April 2011
November 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01320358 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Reliability, Safety and Usability of the Transplantation Sensor System Combined With Myfortic® in Adult Kidney Transplant Patients
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

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Detection Accuracy
  • Patient Compliance
Drug: ECMPS-IEM
ECMPS-IEM
Experimental: ECMPS-IEM
Intervention: Drug: ECMPS-IEM
Fine RN, Becker Y, De Geest S, Eisen H, Ettenger R, Evans R, Rudow DL, McKay D, Neu A, Nevins T, Reyes J, Wray J, Dobbels F. Nonadherence consensus conference summary report. Am J Transplant. 2009 Jan;9(1):35-41. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01320358
CPRO400A2201
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
  • Proteus Digital Health, Inc.
  • Quintiles
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP