JPRN-jRCT2080225371已完成2 期
A randomized, double-blind, parallel group, placebo-controlled, multi-center study to assess the safety and tolerability of monthly subcutaneous administrations of a low and high dose cohort of osocimab to ESRD patients on regular hemodialysis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 859
研究概览
简要总结
Compared with placebo, osocimab treatment was not associated with an increased risk of bleeding in a broad spectrum of ESRD patients on hemodialysis and was generally safe and well-tolerated.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participants must be at least 18 years of age
- •- Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for >= 3 months, receiving dialysis at least 9 hours a week and stable in the view of the investigator
- •- Body weight of at least 50 kg
- •- Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
排除标准
- •- Recent (<6 months before screening) clinically significant bleeding
- •- Hemoglobin (Hb) < 9.0 g/dL at screening
- •- Platelet count < 100 x 109/L
- •- aPTT or PT > ULN (upper limit of normal)
- •- Hepatic disease associated with ALT > 3x ULN, or total bilirubin > 2x ULN with direct bilirubin > 20% of the total
- •- Sustained uncontrolled hypertension (diastolic blood pressure >= 00 mmHg and/or systolic blood pressure >= 180 mmHg)
- •- Known intracranial neoplasm, arteriovenous malformation or aneurysm
- •- Known bleeding disorders e.g. von-Willebrand disease or Hemophilia A, B or C
- •- Recent (<3 months before screening) thromboembolic event, e.g. acute coronary syndrome, stroke or VTE (except dialysis access thrombosis)
- •- Recent (<3 months before screening) major surgery or scheduled major surgery during study participation
- •- Scheduled living donor renal transplant during study participation
- •- Persistent heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher
- •- Receiving antiplatelet therapy except daily ASA =< 150 mg/day
- •- Receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure
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