A Phase 1 Study of LJPC-501 in Patients With Hepatorenal Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Adverse events through 5 days of treatment
研究概览
简要总结
Hepatorenal syndrome (HRS) is a life-threatening condition marked by rapid decline in kidney function in patients with liver cirrhosis or fulminant liver failure. Vasodilation in the gastrointestinal region is largely thought to contribute to the disease. LJPC-501 is a vasoconstrictor that may restore proper circulation and kidney function in patients with HRS.
详细描述
Vasoconstrictors are considered a promising approach to treat HRS due to the significant vasodilation of the splanchnic circulation that contributes to systemic arterial underfilling and leads to functional decline of the kidney in these patients. Vasoconstrictors currently in use are associated with reduced organ perfusion and have marginal effect on sodium excretion. The vasoconstrictor angiotensin II has been shown to produce significant sodium excretion and urine output in patients with cirrhosis and ascites, supporting its potential utility in the treatment of HRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 with HRS, as defined by the International Ascites Club [1]:
- •Cirrhosis with ascites
- •Serum creatinine > 1.5 mg/dL
- •No improvement of serum creatinine (decrease to a level of ≤ 1.5 mg/dL) after at least 2 days with diuretic withdrawal and volume expansion with albumin
- •Absence of shock
- •No current or recent treatment with nephrotoxic drugs
- •Absence of parenchymal kidney disease, as indicated by proteinuria > 500 mg/day, microhematuria (> 50 red blood cells per high power field) and/or abnormal renal ultrasonography
- •Or patients with HRS due to acute alcoholic hepatitis
- •Patient is able to undergo a reliable neurologic exam, as determined by the investigator
- •Patient or legal surrogate is willing and able to provide written informed consent
- •Patient is willing and able to comply with all protocol requirements
排除标准
- •Evidence of shock
- •Current or recent treatment with nephrotoxic drugs
- •Use of midodrine, octreotide, or other vasopressors within 48 hours of screening
- •Current treatment with dialysis
- •Serum creatinine > 7 mg/dL
- •Active cardiovascular disease within 3 months of screening
- •History of transient ischemic attacks or prior stroke
- •History of organ transplant
- •Ongoing infection requiring intravenous administration of antibiotics (patients with documented infections considered by the Investigator to be controlled within 48 hours of screening may be permitted in the study upon consultation with the Sponsor's Medical Monitor)
- •Participation in a clinical trial within 30 days of screening
- •Patient unlikely to survive more than 72 hours in the opinion of the investigator
- •Patient is pregnant or planning to become pregnant during study
研究组 & 干预措施
LJPC-501
LJPC-501, continuous infusion
干预措施: LJPC-501 (Drug)
结局指标
主要结局
Adverse events through 5 days of treatment
时间窗: 5 days
次要结局
- Maximum Tolerated Dose(5 days)
- Effects on serum creatinine through 5 days of treatment(5 days)
- Effects on ascites through 5 days of treatment(5 days)
- Effects on urine output through 5 days of treatment(5 days)
- Effects on sodium excretion through 5 days of treatment(5 days)