NCT00772382已完成3 期
A Phase III, Multi-center, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 21
- 主要终点
- Number of Adverse Events (AE)
研究概览
简要总结
The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia.
The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Male or female, and is >=18 years old
- •Stable hemodialysis or peritoneal dialysis
- •Subjects have stable phosphate control
- •Subjects on stabilized phosphorus diet
- •Subjects undergoing regular dialysis treatment
- •Females and of child-bearing potential have a negative serum pregnancy test
- •Male subjects must agree to use appropriate contraception
排除标准
- •Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose him/her to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study
- •serum albumin level < 3.0g/L
- •PTH level > 1000pg/mL
- •Hemoglobin level < 8mg/dL
- •A History of significant gastrointestinal motility problems
- •Biliary obstruction or proven liver dysfunction
- •A positive test for HIV 1 and 2 antibodies
- •A history of substance or alcohol abuse within the last year
- •Seizure disorders
- •A history of drug or other allergy
- •using cholestyramine, colestipol or colesevelam
- •Schedule to receive a kidney transplant within the next 6 months
- •Participation in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent
研究组 & 干预措施
MCI-196
Experimental
干预措施: MCI-196 (Drug)
结局指标
主要结局
Number of Adverse Events (AE)
时间窗: 52 weeks
次要结局
- The Change in Serum Phosphorus From Baseline to Week 52(52 weeks)
研究者
研究点 (21)
Loading locations...
相似试验
已完成
2 期
Extension Study of MT-1303 in Subjects With Crohn's DiseaseCrohn's DiseaseNCT02389790Mitsubishi Tanabe Pharma Corporation46
已完成
3 期
Long-Term Safety Study of Retigabine Immediate Release (IR) as Adjunctive Therapy in the Treatment of Adults With Partial-Onset Seizures (POS)EpilepsyNCT01336621GlaxoSmithKline98
已完成
3 期
Investigation of the Safety and Pharmacology of Dry Powder Inhalation of TreprostinilPrimary Pulmonary HypertensionNCT03399604Liquidia Technologies, Inc.121
终止
2 期
Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT01238991Pfizer53
终止
1 期
Exploratory Study of IMM01 for Injection in the Treatment of Refractory or Recurrent Hematologic MalignancyHematologic MalignancyNCT05860075ImmuneOnco Biopharmaceuticals (Shanghai) Inc.73