EUCTR2006-006843-29-IT进行中（未招募）1 期
KW-3902IV in the Treatment of Subjects with Worsening Renal Function and Heart Failure Requiring Intravenous Therapy. A multicenter, randomized, double-blind, placebo-controlled study of the effects of KW-3902 Injectable Emulsion on heart failure signs and symptoms, diuresis, renal function, and clinical outcomes in subjects hospitalized with worsening renal function and heart failure requiring intravenous therapy - Reach UP (CKI-303)
ovaCardia Inc.0 个研究点目标入组 480 人开始时间: 2007年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 480
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Able to provide written informed consent, or a legally authorized representative is able to provide written informed consent
- •Male or female 18 years of age or greater
- •Dyspnea at rest or with minimal exertion at randomization
- •Fluid overload as manifested by at least one of the following present at randomization:JVP >10 cm, OR Pulmonary rales ≥1/3 up the lung fields, not clearing with cough,OR≥2+ peripheral or pre-sacral edema
- •Estimated creatinine clearance (CrCl) between 20?60 mL/min usingthe Cockcroft-Gault equation (corrected for height in edematoussubjects ≥100 kg) based on a serum creatinine (SCr) value drawnwithin approximately 6 hours of randomization
- •Worsening renal function as manifested by one of the followingpresent at randomization:An increase in SCr of at least 25% or at least 0.3 mg/dL from the time of initial presentation for this hospitalization in patients hospitalized with heart failure requiring IV diuretic therapy, OR A documented increase in SCr over the preceding 30 days prior to randomization of at least 40% or at least 0.3 mg/dL in patients being admitted for heart failure requiring IV therapy (these patients must be randomized within 24 hours of admission)
- •Anticipated need for IV diuretic treatment for at least 48 hours after the start of study drug
- •BNP >500 pg/mL or NT-pro-BNP >2000 pg/mL
- •Systolic blood pressure ≥90 mmHg at randomization. Subjects with systolic blood pressure of 85-89 mmHg at randomization may be included if their usual systolic blood pressure measurements are consistently within 85-89 mmHg while clinically stable.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous exposure to KW-3902
- •Pregnant or breast feeding women.
- •3.Any administration of IV radiographic contrast within 14 days of
- •randomization or any procedures with IV radiographic contrast
- •Severe pulmonary disease
- •Significant stenotic mitral or aortic valvular disease
- •Heart transplant recipient or admitted for cardiac transplantation or
- •LVAD surgery
- •Any major surgery within 2 weeks prior to screening (cardiac or
- •non-cardiac)
- •Allergy to soybean oil or eggs
- •History of seizure (except febrile seizure)
- •Stroke within 2 years
- •History of brain tumor of any etiology
- •Brain surgery within 2 years
- •Encephalitis/meningitis within 2 years
- •History of penetrating head trauma
- •Closed head injury with loss of consciousness (LOC) over 30 minutes within 2 years
- •History of or at risk for alcohol withdrawal seizures
- •34.Advanced Alzheimer?s disease
- •35.Advanced multiple sclerosis
研究者
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