NCT00448071Unknown2 期
A Phase II, Randomized Double Blind Placebo-Controlled, Dose Escalating Study to Determine Pharmacokinetic and Pharmacodynamic Effects of MTR107 in End-Stage Renal Disease (ESRD) Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- A descriptive pharmacokinetic / pharmacodynamic study. No primary end-points apply.
研究概览
简要总结
MTR107 effect on blood pressure throught the dialysis procedure and its ability to prevent Intra dialytic Hypotension
详细描述
The present clinical trial aims to investigate and provide a more precise characterization of the pharmacokinetic and pharmacodynamic profile of MTR107 in a population of ESRD patients predisposed to developing intradialytic hypotension. The study is also designed as a dose esclating study aiming to assess MTR107 safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-75 years, inclusive.
- •Presence of frequent bouts of hypotension defined as 3 or more intradialytic hypotensive events per month for the last six months prior to baseline, despite standard adjustments in dry weight.
- •ECG performed up to one month before study start.
- •Well-preserved hepatic function (within normal laboratory ranges) at study entry as judged by:
- •Serum Bilirubin (Total Bilirubin (direct and indirect) 0.3-1.0 mg/dL, and Direct Bilirubin 0.1-0.5 mg/dL)
- •Serum Albumin (>3.6 g/dL),
- •Serum aminotransferases (AST (0-37 U/L) and ALT (0-40 U/L)),
- •GGT (Gamma Glutamine Trans Peptidase)
- •Normal coagulation status at study entry as judged by PT-INR, PTT, fibrinogen and platelet count.
- •Willingness to participate in the study and adhere to the study design.
- •Willingness to sign an informed consent form.
排除标准
- •Uncontrolled hypertension >140/90 mmHg.
- •Unstable angina.
- •Abnormal ECG which may indicate acute disease
- •Variable weight gains.
- •Mental retardation.
- •Malignancy or other concomitant serious diseases.
- •Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days.
结局指标
主要结局
A descriptive pharmacokinetic / pharmacodynamic study. No primary end-points apply.
次要结局
- Exploratory Efficacy Parameters:
- Number and type of medical interventions required for treatment of hypotension.
- Alleviation of symptoms associated with intradialytic hypotension.
- Efficiency of dialysis as reflected by Kt/V
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Effect of Intradialytic Electrical Muscle Stimulation and Passive Leg Mobilisation on Blood Pressure and Dialysis EfficacyHypotensionNCT00328289Insel Gruppe AG, University Hospital Bern12
已完成
3 期
Fimasartan in the Senior SubjectsThe Elderly (≥ 70 Years) With Essential HypertensionNCT03246555Boryung Pharmaceutical Co., Ltd241
已完成
2 期
Blood Pressure Lowering in Dialysis (BOLD) TrialBlood PressureEnd Stage Renal Disease on Dialysis (Diagnosis)Chronic Kidney DiseasesChronic Kidney Disease Stage 5NCT03459807University of California, San Francisco50
已完成
2 期
A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood PressureHypertensionNCT00422461Pfizer135
已完成
4 期
Loop Diuretics in Chronic Kidney DiseaseChronic Kidney DiseaseNCT00478543University of Campania "Luigi Vanvitelli"40