NCT01320358已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- To assess the reliability of the Raisin technology defined as accuracy and precision in detecting directly observed ingestion of ECMPS-IEM and Placebo-IEM.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ECMPS-IEM
Experimental
干预措施: ECMPS-IEM (Drug)
结局指标
主要结局
To assess the reliability of the Raisin technology defined as accuracy and precision in detecting directly observed ingestion of ECMPS-IEM and Placebo-IEM.
时间窗: 12 weeks
次要结局
- the satisfaction and usability of the TSS by patients(12 weeks)
- 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)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
不适用
Clinical Trial for the Assessment of Safety, Usability and Efficacy of the Vixe Combination for OAB in Female SubjectsOveractive BladderNCT06345677Vensica Therapeutics Ltd.48
已完成
3 期
Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive TherapyMajor Depressive Disorder (MDD)NCT02012218Otsuka Pharmaceutical Development & Commercialization, Inc.61
已完成
不适用
An Investigator-initiated, Explorative Trial Evaluating the Effect of SAT-008 in Healthy AdultsAllergy and ImmunologyNCT04916145Seoul National University Bundang Hospital42
已完成
3 期
Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip OsteoarthritisOsteoarthritis, HipNCT00154219Novartis1,200
Unknown
不适用
Safety and Efficacy Study of the Z-Lig Medical Device Compared to AllograftRuptured Anterior Cruciate LigamentsNCT01245400Aperion Biologics, Inc.60