Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
The purpose of this study is to examine the effects of the digibind drug on hemodialysis patients with high blood pressure. Digibind is used to treat toxicity from digoxin and digoxin-like molecules which may contribute to high blood pressure.
详细描述
High blood pressure is a very common problem in patients with kidney disease. Researchers have noted that there are certain molecules in the blood of these patients that may be contributing to the high blood pressure. In particular these molecules have been labeled as "digoxin-like substances." Digoxin is a drug made from a certain plant that may contribute to high blood pressure. In research animals with kidney failure, it has been noted that the use of Digibind helps to lower the blood pressure in these animals. Digibind is a drug made from sheep that is used to treat the toxicity from digoxin as well as toxicity from molecules similar to digoxin.
In this study, volunteers that are on hemodialysis and have high blood pressure will be given a placebo or the digibind drug intravenously on two separate visits. The volunteers will then wear a 24-hour blood pressure monitor and return the following day. Volunteers will receive the Digibind at one visit during the study, and the placebo on the other visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years of age
- •On hemodialysis with predialysis BP > 150/90 but ≤ 180/110
- •On at least one anti-hypertensive medication for 6 consecutive readings
- •Able to have blood pressure measured in an arm
- •Women of child bearing potential must not be pregnant; must use contraception during the study and for one month after the study
- •Receiving adequate dialysis (KT/V > 1.2)
- •Compliant with the dialysis schedule and duration
排除标准
- •Pregnant or nursing women
- •Arm blood pressure is not possible to obtain
- •Currently on digitalis
- •On any Digibind-type product in the past
- •History of allergies to antibiotics
- •History of asthma
- •Medical or psychiatric disorders which are unstable or which might interfere with study assessments or safe participation in the study
- •History of use of, or evidence of need for, digitalis-like products
- •Inability to understand or provide informed consent
研究组 & 干预措施
Low
0.1mg/kg
干预措施: Digoxin immune fab (Drug)
Medium
0.4mg/kg
干预措施: Digoxin immune fab (Drug)
High
1.6 mg/kg
干预措施: Digoxin immune fab (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Blood pressure
时间窗: Screening, and 24-hour period after first infusion and after second infusion
次要结局
- Marinobufagenin levels(Screening, and after first and second infusions)