A Phase 2B, Double-blind, Randomized, Placebo-controlled, Proof-of-concept Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- The proportion of patients who achieve two consecutive > or = 30% decreases from his/her baseline serum iPTH level
研究概览
简要总结
The goal of this study is to test a new vitamin D compound for its ability to reduce parathyroid hormone levels in patients who are on hemodialysis.
详细描述
This is a randomized, double-blind, placebo-controlled study of the vitamin D analog 2-methylene-19-nor-20S-1α,25-dihydroxyvitamin D3 (DP001) in patients with end-stage renal disease (ESRD). The effect of 12 weeks of oral administration of DP001 on serum parathyroid hormone (PTH) levels will be evaluated in ESRD patients who have secondary hyperparathyroidism.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men and non-pregnant women ≥18 years of age
- •Patient is diagnosed with ESRD and must be on hemodialysis 3 times per week for at least 3 months prior to Screening Phase
- •Patient is currently being treated with pharmaceutical vitamin D for the treatment of secondary hyperparathyroidism
- •Serum iPTH value ≤500 pg/mL at first screening visit
- •Total serum calcium (corrected for albumin) ≤10.5 mg/dL at first screening visit
- •Serum phosphorus ≤7.0 mg/dL at first screening visit
排除标准
- •Currently taking any of the following: drugs affecting vitamin D metabolism, digitalis, glucocorticoids, cyclosporine or other immunosuppressants, aluminum-based phosphate binders
- •A daily intake >4000 IU vitamin D (D3 + D2)
- •Any investigational drug use within 10 half-lives of the drug (or within the previous 30 days if the half-life of the drug is unknown)
- •History of any of the following: ventricular dysrhythmias, severe congestive heart failure, angina pectoris, myocardial infarction, coronary angioplasty, coronary artery bypass grafting, multiple myeloma, calciphylaxis, active malignancy, end-stage liver disease, active infections, clinically significant renal/urinary tract stones, sarcoidosis, tuberculosis, parathyroidectomy
- •Major surgery within the past 3 months
研究组 & 干预措施
DP001
DP001 softgel capsules, 440 ng taken orally three times weekly after dialysis for 12 weeks
干预措施: DP001 softgel capsules (Drug)
Placebo
Placebo softgel capsules, taken orally three times weekly after dialysis for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
The proportion of patients who achieve two consecutive > or = 30% decreases from his/her baseline serum iPTH level
时间窗: 12 weeks, with weekly iPTH measurements
次要结局
- Mean percentage change in serum iPTH(Baseline to 12 weeks)