EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 3,883
- 主要终点
- Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)
研究概览
简要总结
The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who are receiving dialysis.
详细描述
Secondary HPT is common in people with CKD. Patients with secondary HPT often have high parathyroid hormone (PTH) levels and may develop large parathyroid glands in the neck. Patients with secondary HPT may have bone disease (osteodystrophy). This bone disease may cause bone pain, fractures, and poor formation of red blood cells. Other problems from secondary HPT may include increases in blood levels of calcium and phosphorus. These may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), or heart and lung problems. New evidence suggests that secondary HPT is associated with cardiovascular disease and increased death risk. The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events (having to do with the heart and its blood vessels) and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who are receiving dialysis. These events include death from any reason, heart attack and episodes where the heart does not get enough oxygen, peripheral vascular disease (narrowing of vessels that carry blood to the legs, arms, stomach or kidneys), and heart failure (a condition that occurs when the heart is unable to pump enough blood to meet the need's of the body's tissues)
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 (Participant, 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
- •Inclusion:≥ 18 years of age
- •Treated with maintenance hemodialysis - PTH ≥ 300 pg/mL (31.8 pmol/L)
- •serum calcium ≥ 8.4mg/dL (2.1 mmol/L)
- •Ca x P ≥ 45 mg2*/dL2 (3.63 mmol2/L2)
排除标准
- •Exclusion:
- •Parathyroidectomy in the 12 weeks before the date of informed consent
- •Received therapy with cinacalcet within 3 months of randomization
- •Hospitalization within 12 weeks of randomization for any of the following events: a. Myocardial ischemia b. Unstable angina c. Heart Failure (HF) (including any unplanned presentation to a health care facility that would require mechanical intervention [i.e., unplanned dialysis treatment]) d. Peripheral vascular disease (other than dialysis vascular access revision) e. Stroke
- •History of seizure within 12 weeks prior to randomization
- •Scheduled date for kidney transplant from a known living donor
- •Anticipated parathyroidectomy within 6 months after randomization
- •in all instances, the 2 refers to squared.
研究组 & 干预措施
Cinacalcet
干预措施: Cinacalcet (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)
时间窗: From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years
Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event). Stratified by history of diabetes and country.
次要结局
- Time to Myocardial Infarction(From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years)
- Time to Heart Failure(From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years)
- Time to Peripheral Vascular Event(From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years)
- Time to Bone Fracture(From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years)
- Time to All-cause Mortality(From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years)
- Time to Stroke(From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years)
- Time to Hospitalization for Unstable Angina(From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years)
- Time to Cardiovascular Mortality(From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years)
- Time to Parathyroidectomy(From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years)