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

Patient Compliance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320358
• Other study ID #: CPRO400A2201
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2011
• Last updated: February 20, 2017
• Start date: May 10, 2011
• Est. completion date: November 18, 2011

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 18, 2011
• Est. primary completion date: November 18, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Detection Accuracy
• Patient Compliance

Intervention

Drug:
• ECMPS-IEM
ECMPS-IEM

Locations

Country	Name	City	State
Switzerland	Kantonspital Aarau AG / Nephrologie	Aarau
Switzerland	University Hospital Basel	Basel
Switzerland	Inselspital Bern / Nephrology	Bern
Switzerland	Stadtspital Waid Zurich	Zurich
Switzerland	University Hospital Zurich	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Proteus Digital Health, Inc., Quintiles, Inc.

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Eisenberger U, Wüthrich RP, Bock A, Ambühl P, Steiger J, Intondi A, Kuranoff S, Maier T, Green D, DiCarlo L, Feutren G, De Geest S. Medication adherence assessment: high accuracy of the new Ingestible Sensor System in kidney transplants. Transplantation. — View Citation

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. doi: 10.1111/j.1600-6143.2008.02495.x. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the reliability of the Raisin technology defined as accuracy and precision in detecting directly observed ingestion of ECMPS-IEM and Placebo-IEM.		12 weeks
Secondary	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.		12 weeks
Secondary	the incidence and severity of adverse events observed during the utilization of the ECMPS-IEM and Proteus Personal Monitor (patch).		12 weeks
Secondary	the satisfaction and usability of the TSS by patients		12 weeks

External Links

•   Results for CPRO400A2201 from the Novartis Clinical Trials Website