NCT06690242已完成2 期
A Multicenter, Randomized,Positive Controlled, and Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of MT1013 Injection in Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism Undergoing Maintenance Hemodialysis
Shaanxi Micot Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2024年11月4日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Percentage of participants with > 30% reduction from baseline in mean iPTH during the efficacy assessment phase
研究概览
简要总结
This is a randomized, positive controlled, and placebo-controlled phase II clinical study to evaluate the efficacy and safety of MT1013 injection in the treatment of chronic kidney disease with secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis (MHD) subjects.
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
- Single (Participant)
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
- •1. Subject capable of understanding written information ,willing to participate in, and provide a written informed consent;
- •2.Male or female subjects must be at least 18 years old when signing the informed consent;
- •3.The subjects must undergo regular maintenance hemodialysis three times a week for at least three months；
- •4.Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);
- •5.Diagnosed of Secondary Hyperparathyroidism (SHPT), with averaged iPTH ≥400 pg/ml14 days prior to screening;
- •6.Receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 1 month prior to screening, remain stable;
- •7.Subject receiving calcium supplements, or phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening, remain stable;
排除标准
- •1.The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study;
- •2.Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
- •3.The body mass index of the subjects was less than 18kg/m2 or greater than 35 kg/m2;
- •4.Subjects with severe uncontrolled hypertension, defined as systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg(Except for transient blood pressure abnormalities seen during dialysis), despite optimal drug treatment prior to enrollment;
- •5.History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
- •6.Subjects with a history of malignant tumors within the past 5 years prior to screening;
- •7.Subjects are allergic or intolerant to any component of the investigational drug or Etelcalcetide
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo administered intravenously (IV) three times per week for 26 weeks;
干预措施: Placebo (Drug)
MT1013 dose regimen 2
Experimental
MT1013 injection dose regimen 2 administered intravenously (IV) three times per week for 26 weeks.
干预措施: MT1013 (Drug)
MT1013 dose regimen 1
Experimental
MT1013 injection dose regimen 1 administered intravenously (IV) three times per week for 26 weeks.
干预措施: MT1013 (Drug)
Etelcalcetide
Active Comparator
Etelcalcetide injection administered intravenously (IV) three times per week for 26 weeks.
干预措施: Etelcalcetide Hydrochloride (Drug)
结局指标
主要结局
Percentage of participants with > 30% reduction from baseline in mean iPTH during the efficacy assessment phase
时间窗: Weeks 22 to 27, inclusive
次要结局
- Percentage of participants with > 50% reduction from baseline in mean iPTH during the efficacy assessment phase(Weeks 22 to 27, inclusive)
研究者
研究点 (1)
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