NCT00609544撤回2 期
A Multi-Center, Double-Blind, Placebo-Controlled Safety and Preliminary Efficacy Study of IL-1 Trap (Rilonacept) Administered Subcutaneously in Subjects With Non Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) and Anemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change in blood hemoglobin concentration.
研究概览
简要总结
Anemia of inflammation is a common complication in patients with chronic kidney disease (CKD). Patients with CKD and anemia of inflammation also exhibit decreased response to erythropoietic agents, even in the presence of adequate iron stores. This decreased responsiveness is associated with increased levels of proinflammatory cytokines. Rilonacept is being developed for the treatment of inflammatory disorders.
This is a clinical research study to determine the safety and effectiveness of rilonacept for the treatment of anemia in inflamed patients with CKD who are not yet on dialysis.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female greater than 18 years of age
- •Chronic Kidney Disease (CKD) not yet requiring renal replacement therapy (pre-dialysis patients)
- •Not expected to require dialysis during duration of the study
- •Adequate laboratory values
- •If on rHuEPO therapy, the dose must be stable
排除标准
- •Persistent chronic or active infections
- •Intravenous (IV) iron administration within 12 weeks prior to the Screening Visit
- •Known history of severe uncontrolled hyperparathyroidism
- •Prior recipient or scheduled to receive a kidney transplant during the study
- •Abnormal laboratory values
- •Unstable angina or myocardial infarction within the past 6 months prior to the Screening Visit
- •Uncontrolled hypertension
- •Coronary disease diagnosed in the 3 months prior to the Screening Visit
- •Severe Congestive Heart Failure
- •History of HIV
- •Hepatitis B and/or Hepatitis C
- •Abnormal chest radiograph
- •A positive intradermal skin tuberculin test
- •History or presence of cancer within 5 years of the Screening Visit
- •History of alcohol abuse or current intake of 21 or more alcohol-containing drinks per week
- •History of drug abuse within the 5 years prior to the Screening Visit
- •Lactating females or pregnant females
研究组 & 干预措施
1
Experimental
干预措施: Rilonacept (Drug)
2
Placebo Comparator
干预措施: Rilonacept (Drug)
结局指标
主要结局
Change in blood hemoglobin concentration.
时间窗: Baseline to Week 12
次要结局
未报告次要终点
研究者
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