A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) and Iron Sucrose in Subjects With Iron Deficiency Anemia (FERWON-IDA)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,512
- 试验地点
- 3
- 主要终点
- Change in Hemoglobin (Hb) From Baseline to Week 8
研究概览
简要总结
Evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®) compared with iron sucrose (Venofer®), in subjects diagnosed with IDA.
详细描述
IDA is highly prevalent condition in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure or surgery. IDA can have a substantial medical and quality of life (QoL) burden. Treatment of subjects diagnosed with IDA includes controlling the bleeding and replenishing lost iron.
This study was designed to evaluate the safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose in subjects diagnosed with IDA. In a subfraction of 35 subjects treated with iron isomaltoside/ferric derisomaltose, ECG and iron will be frequently measured.
The study subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or iron sucrose (200 mg IV injections at baseline and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline; a cumulative dose of 1000 mg was recommended). The study subjects were monitored for up to 8 weeks from baseline.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Iron isomaltoside/ferric derisomaltose
Administered IV
干预措施: Iron isomaltoside/ferric derisomaltose (Drug)
Iron sucrose
Administered IV
干预措施: Iron sucrose (Drug)
结局指标
主要结局
Change in Hemoglobin (Hb) From Baseline to Week 8
时间窗: Baseline to week 8
Efficacy Evaluate the effect on the hemoglobin (Hb) level following treatment with iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with iron deficiency anaemia (IDA) . Response was defined as change from baseline in hemoglobin (Hb) to week 8, i.e. ability to increase Hb in subjects with IDA, when oral iron preparations were ineffective or could not be used or in whom the screening Hb measurement in Investigators' opinion were sufficiently low to require rapid repletion of iron stores.
Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
时间窗: Baseline to week 8
Safety For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness. The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC). Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions.
次要结局
- S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8(Baseline, week 1, 2, 4, and 8)
- Composite Cardiovascular Adverse Events (AEs)(Baseline, week 1, 2, and 8)
- Time to First Composite Cardiovascular Safety AE(Baseline, week 1, 2, 4, and 8)
- S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8(Week 1 to week 8)
- Change in Hb Concentration From Baseline to Week 1, 2, and 4(Baseline, week 1, 2, and 4)
- Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8(Baseline, week 1, 2, 4, and 8)
- Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8(Baseline, week 1, 2, 4, and 8)
- Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8(Baseline, week 1, 2, 4, and 8)
- Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8(Baseline, week 1, 2, 4, and 8)
- Time to Change in Hb Concentration ≥2 g/dL(Baseline, week 1, 2, 4, and 8)
- Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8(Week 1 to week 8)
- Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8(Week 1 to week 8)
- Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8(Baseline, week 1, 2, and 8)
- Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking(Baseline)
- Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car(Baseline)
- Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit(Baseline)
- Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits(Baseline)
- Health Care Resource Use Questionnaire(Baseline)