An Open-label, Multicentre, Extension Trial to Assess the Safety of Re-dosing of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 3
- 主要终点
- Number of Subjects With Adverse Drug Reactions (ADR)
研究概览
简要总结
Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.
详细描述
Among the various formulations of parenteral iron that are currently available, iron isomaltoside/ferric derisomaltose may allow flexibility in terms of high and rapid dosing. Up to now, most clinical trials with intravenous (IV) iron treatment were of 4-12 weeks in duration; longer trials are warranted to follow-up on long-term safety.
The aim of the trial was to evaluate the safety and efficacy of IV iron isomaltoside/ferric derisomaltose re-dosing in subjects who were previously treated with iron isomaltoside/ferric derisomaltose in lead-in trials.
This was a 6-months extension trial lasting 26 weeks. Eligible subjects attended 5 visits: screening, baseline (subjects treated with a single IV dose of 1000 mg iron isomaltoside/ferric derisomaltose), and follow-up visits at week 2, 13, and 26 weeks after the IV dose, for safety and efficacy assessments.
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
- •Completed one of the lead-in trials
- •Randomised and dosed with iron isomaltoside/ferric derisomaltose in one of the lead-in trials.
- •Haemoglobin (Hb) of ≤ 11 g/dL
- •Screening serum ferritin (s-ferritin) ≤ 100 ng/mL, or ≤ 300 ng/mL if transferrin saturation (TSAT) ≤ 30 %
- •Willingness to participate and signing the informed consent form (ICF)
排除标准
- •Intravenous (IV) iron treatment between the lead-in trial and screening
- •During 30-day period prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
- •Received an investigational drug within 30 days of screening
- •Decompensated liver cirrhosis or active hepatitis
- •Pregnant or nursing women.
- •Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements
研究组 & 干预措施
Iron isomaltoside/ferric derisomaltose
Administered IV
干预措施: Iron isomaltoside/ferric derisomaltose (Drug)
结局指标
主要结局
Number of Subjects With Adverse Drug Reactions (ADR)
时间窗: Baseline to week 26
Safety Evaluate the number of subjects with adverse drug reactions (ADRs), defined as AEs that were assessed by the investigator as related or possible related to the investigational product.
次要结局
- Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions(Baseline to week 26)
- Composite Cardiovascular Adverse Events (AEs)(Baseline to week 26)
- Time to First Composite Cardiovascular Safety AE(Baseline, week 2, 13, and 26)
- S-phosphate <2 mg/dL at Any Time From Baseline to Week 26(Baseline to week 26)
- Change in Hb From Baseline to Week 2, 13, and 26(Baseline, week 2, 13, and 26)
- Change in S-ferritin From Baseline to Week 2, 13, and 26(Baseline, week 2, 13, and 26)
- Change in Transferrin Saturation (TSAT) From Baseline to Week 2, 13, and 26(Baseline, week 2, 13, and 26)
- Change in S-iron From Baseline to Week 2, 13, and 26(Baseline, week 2, 13, and 26)