NCT01340482已完成1 期
A Phase I/II, Open-Label, Repeat-Dose, Dose-Escalation Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 6
- 主要终点
- Safety and Efficacy of Repeated SC Injections of KRN23
研究概览
简要总结
The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH). A Bone Substudy will evaluate the effects of single-blind KRN23 versus Placebo on bone mineral density and bone quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •18 years or older
- •Clinical diagnosis of XLH
- •TmP/GFR < 2.0 mg/dL
- •GFR ≥60 mL/min
- •Corrected Ca <10.8 mg/dL
- •A willingness to utilize adequate contraception and not become pregnant[or to have their partner(s) become pregnant] during the study
- •Additional inclusion criteria apply
排除标准
- •Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within 3-weeks of Screening
- •History of known immunodeficiency
- •Pregnant or lactating females subjects or female planning to be become pregnant during the study
- •Receipt of a live (attenuated) vaccine (except for influenza vaccines) within 3-months of Screening, and/or during the study
- •Use of pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10-days prior to Screening and/or dosing
- •Use of any supplement containing phosphate, calcium and/or vitamin D within 10-days prior to Screening and/or dosing
- •Condition which could present a concern for either the subject's safety or difficulty with data interpretation
- •Additional exclusion criteria apply
研究组 & 干预措施
KRN23
Experimental
Escalating doses of KRN23 (0.05, 0.10, 0.30 and 0.60 mg/kg) will be administered SC every 28 days (up to 4 doses)
干预措施: KRN23 (Drug)
结局指标
主要结局
Safety and Efficacy of Repeated SC Injections of KRN23
时间窗: On-Treatment: 6.5 months, 27 total visits
Safety and efficacy of repeated SC injections of KRN23 from baseline as assessed by serum phosphorus levels,immunogenicity, adverse events and clinically significant changes in vital signs and laboratory testing.
次要结局
- Evaluation of Effect of Repeated SC Injections of KRN23(On-Treatment: 6.5 months, 27 total visits)
研究者
研究点 (6)
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