NCT01320358

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 10, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2011

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

March 21, 2011

Last Update Submit

February 20, 2017

Conditions

Detection AccuracyPatient Compliance

Keywords

Patient complianceECMPS-IEMtransplantationrenal maintenanceProteus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • the incidence and severity of adverse events observed during the utilization of the ECMPS-IEM and Proteus Personal Monitor (patch).

    12 weeks

  • the satisfaction and usability of the TSS by patients

    12 weeks

Study Arms (1)

ECMPS-IEM

EXPERIMENTAL
Drug: ECMPS-IEM

Interventions

ECMPS-IEMDRUG

ECMPS-IEM

ECMPS-IEM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Kantonspital Aarau AG / Nephrologie

Aarau, 5001, Switzerland

Location

University Hospital Basel

Basel, 4000, Switzerland

Location

Inselspital Bern / Nephrology

Bern, 3010, Switzerland

Location

Stadtspital Waid Zurich

Zurich, 8037, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 19133930BACKGROUND

  • Eisenberger U, Wuthrich RP, Bock A, Ambuhl 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. 2013 Aug 15;96(3):245-50. doi: 10.1097/TP.0b013e31829b7571.

    PMID: 23823651RESULT

MeSH Terms

Conditions

Patient ComplianceProteus Infections

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 22, 2011

Study Start

May 10, 2011

Primary Completion

November 18, 2011

Study Completion

November 18, 2011

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

CH(5)