NCT05663411进行中（未招募）2 期
An Open-label, Randomized, Active-Controlled Dose Titration Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change From Baseline in serum iPTH
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of SHR6508 for Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.
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
- 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
- •Able and willing to provide a written informed consent
- •Diagnosed with end stage renal disease receiving stable hemodialysis
- •Male or female
- •Meet the Body Mass Index standard
- •Stably use of concomitant medication of other therapies of SHPT
- •Meet the standard of iPTH level, cCa and HB
排除标准
- •Subjects with a history of malignant tumor
- •Subjects with neuropsychiatric diseases
- •Subjects with a history of cardiovascular diseases
- •Subjects with gastrointestinal diseases
- •Subjects with a history of surgery
- •Subjects with a history of blood loss
- •Subjects with a history of kidney transplant
- •Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin
- •Subjects with a treatment history of similar drugs
- •Allergic to a drug ingredient or component
- •Pregnant or nursing women
- •No birth control during the specified period of time
- •Subject with a history of alcohol abuse and drug abuse
- •Participated in clinical trials of other drugs
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial
研究组 & 干预措施
Treatment group A: SHR6508
Experimental
干预措施: SHR6508 (Drug)
Treatment group B: SHR6508
Experimental
干预措施: SHR6508 (Drug)
Treatment group C: Cinacalcet
Active Comparator
干预措施: Cinacalcet (Drug)
结局指标
主要结局
Change From Baseline in serum iPTH
时间窗: Baseline and the efficacy period, defined as Week 16
iPTH was tested at a central laboratory.
次要结局
- Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline(Baseline and the efficacy period, defined as Week 16)
- Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline(Baseline and the efficacy period, defined as Week 16)
- Change From Baseline in serum cCa and P(Baseline and the efficacy period, defined as Week 16)
- Participants With Treatment-Emergent Adverse Events (TEAEs)(Day1 to End of Study, End of Study is about Week 20)
- Participants with Anti-SHR6508 Antibody at baseline and postbaseline(Day1 to End of Study, End of Study is about Week 20)
研究者
研究点 (1)
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