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ECMPS-IEM

Phase 2

Detection Accuracy | Small molecule | Other |Novartis AG|Last Updated: Feb 23, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

ECMPS-IEM · 1 trial · 2 indications

Phase 2 1
NCT01320358Reliability, Safety and Usability of the Transplantation Sensor System Combined With Myfortic® in Adult Kidney Transplant PatientsDetection Accuracy
COMPLETED30 Analytics
PHASE2COMPLETED
Reliability, Safety and Usability of the Transplantation Sensor System Combined With Myfortic® in Adult Kidney Transplant Patients
Detection Accuracy
NCT0132035830
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE

Treatment Arms

ArmTypeDescription
ECMPS-IEMEXPERIMENTAL -

Interventions

NameTypeDescription
ECMPS-IEMDRUGECMPS-IEM
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

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 t...

Countries:Switzerland
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Frequently asked questions about ECMPS-IEM

What is ECMPS-IEM used for?

ECMPS-IEM is a small molecule being studied for detection accuracy and patient compliance in adult kidney transplant patients. It is an investigational drug-device combination that is being evaluated for its reliability, safety, and usability when combined with Myfortic in this patient population.

Who makes ECMPS-IEM?

ECMPS-IEM is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical research on this investigational product for use in adult kidney transplant patients.

What phase is ECMPS-IEM in?

ECMPS-IEM is in Phase 2 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 2 study has been completed, and the product remains under clinical investigation.

What clinical trials is ECMPS-IEM in?

ECMPS-IEM has one completed Phase 2 clinical trial with the identifier NCT01320358. The study, titled 'Reliability, Safety and Usability of the Transplantation Sensor System Combined With Myfortic® in Adult Kidney Transplant Patients,' enrolled 30 participants in Switzerland.

Is ECMPS-IEM the same as Myfortic?

ECMPS-IEM is not the same as Myfortic. In the clinical trial, ECMPS-IEM is the transplantation sensor system being studied in combination with Myfortic, which is a separate medication. The trial evaluates the reliability, safety, and usability of the sensor system when used alongside Myfortic.