NCT07122401招募中3 期
A Multicenter, Randomized, Double-blind, Double-dummy, Phase III Study to Evaluate the Efficacy and Safety of MT1013 Versus Cinacalcet as Active Control in Secondary Hyperparathyroidism Patients on Maintenance Dialysis
Shaanxi Micot Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 424 人开始时间: 2025年9月30日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 424
- 试验地点
- 1
- 主要终点
- Percentage of participants with > 50% reduction from baseline in mean intact parathyroid (iPTH)
研究概览
简要总结
MT1013 is a first-in-class dual-target agonist. This study is a multicenter, randomized, double-blind, double-dummy phase III clinical study being conducetd to evaluate the efficacy and safety of MT1013 compared with active control cinacalcet in secondary hyperparathyroidism patients on maintenance dialysis. Subjects will be 1:1 randomized to receive MT1013 or cinacalcet for 26 weeks. Evaluations of iPTH, Ca, P, BMD, and biomarkers will be done across the study period, to compare efficacy and safety of MT1013 to cinacalcet.
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
- •Participants capable of understanding written information ,willing to participate in, and provide a written informed consent;
- •Male or female, at least 18 years old, 18 kg/m^2 ≤BMI≤35 kg/m^2;
- •Receiving regular maintenance dialysis 3 times a week for at least 12 weeks prior to screening；
- •Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);
- •Subjects must have a confirmed diagnosis of Secondary Hyperparathyroidism (SHPT), with a mean pre-dialysis serum intact parathyroid hormone (iPTH) level ≥ 400 pg/mL (42.4 pmol/L), based on measurements from two non-consecutive days before dialysis, within 14 days prior to randomization;
- •Within 14 days prior to randomization, subjects must have serum calcium levels (measured pre-dialysis, or corrected serum calcium if albumin <40 g/L) ≥ 8.4 mg/dL (2.1 mmol/L) on two non-consecutive pre-dialysis measurements.
排除标准
- •Underwent parathyroidectomy within 6 months prior to screening, or anticipated parathyroidectomy, ablation or radiation during the study;
- •Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
- •New York Heart Association (NYHA) Class III or IV heart failure within 3 months prior to screening; Symptomatic arrhythmia within 6 months prior to screening; History of torsades de pointes (TdP).
- •QTcF interval >470 ms in males or >480 ms in females on screening ECG, or other clinically significant ECG abnormalities as determined by the Investigator (e.g., third-degree atrioventricular block, sick sinus syndrome, multifocal frequent ventricular premature contractions, ventricular tachycardia, atrial fibrillation, etc.).
- •Subjects with severe uncontrolled hypertension during the screening period are excluded, defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg despite optimal medical therapy prior to enrollment (excluding transient blood pressure abnormalities during dialysis).
- •History of seizure within 1 year prior to screening, or currently receiving treatment for seizure disorders;
- •Received oral cinacalcet or ivocalcet within 14 days prior to screening, or received Etelcalcetide injection treatment within 4 months prior to screening;
- •Any other condition that, in the Investigator's judgment, would make the subject unsuitable for participation in this study.
研究组 & 干预措施
MT1013
Experimental
MT1013 is administered intravenously (IV) for 26 weeks; Dummy cinacalcet will be administered orally for 26 weeks.
干预措施: MT1013 (Drug)
Cinacalcet
Active Comparator
Cinacalcet is administered orally for 26 weeks. Dummy MT1013 is administered intravenously (IV) for 26 weeks.
干预措施: Cinacalcet (Drug)
结局指标
主要结局
Percentage of participants with > 50% reduction from baseline in mean intact parathyroid (iPTH)
时间窗: EAP（Week 22-27）
Percentage of participants with > 30% reduction from baseline in mean iPTH
时间窗: EAP（Week 22-27）
次要结局
- Change From Baseline in Bone Mineral Density(Week 27)
- Change from baseline in serum calcium(EAP（Week 22-27）)
- Change From Baseline in serum phosphorus(EAP（Week 22-27）)
- Safety and Tolerance(Up to Week 30)
研究者
研究点 (1)
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