NCT01102413已完成3 期
A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions or Repeated Bolus Injections in Comparison With Oral Iron Sulphate in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin (Hb) Concentration From Baseline to Week 4.
研究概览
简要总结
The study is designed to determine the effects of an investigational drug Monofer in subjects with non-dialysis dependent chronic kidney disease (NDD-CKD) subjects and with iron deficiency anaemia (IDA).
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
- •Men and women, aged more than 18 years.
- •Subjects diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.
- •Hb < 11.0 g/dL (6.80 mmol/L)
- •Either or both of the following iron stores indicators below target {Serum ferritin < 100 ug/l and Transferrin saturation (TfS)<20%}.
- •Life expectancy beyond 12 months by Principal Investigator's judgement.
- •Willingness to participate after informed consent and any authorization as required by local law ( e.g. Protected Health Information [PHI] for North America).
排除标准
- •Anaemia predominantly caused by factors other than renal impairment or iron deficiency (according to Principal Investigator's judgment).
- •Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).
- •Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate or any excipients of the study drug.
- •Subjects with history of multiple allergies.
- •Decompensated liver cirrhosis or active hepatitis (Alanine Aminotransferase (ALT) > 3 times upper normal limit).
- •Active acute or chronic infections ((assessed by clinical judgment), supplied with White Blood Cells (WBC) and C-Reactive Protein (CRP)).
- •Rheumatoid arthritis with symptoms or signs of active joint inflammation.
- •Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product (5 days): Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
- •Extensive active bleeding necessitating blood transfusion.
- •Planned elective surgery during the study.
- •Participation in any other clinical study within 3 months prior to screening.
- •Known intolerance to oral iron treatment.
- •Untreated B12 or folate deficiency.
- •I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
- •ESA treatment within 8 weeks prior to screening visit.
- •Serum ferritin > 500 µg/L.
- •Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study or interfere with study drug evaluation. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
- •Body weight < 30 kilograms.
研究组 & 干预措施
Monofer
Experimental
Injections or infusions
干预措施: Monofer (Drug)
Iron Sulphate
Active Comparator
Oral intake
干预措施: Iron Sulphate (Drug)
结局指标
主要结局
Change in Hemoglobin (Hb) Concentration From Baseline to Week 4.
时间窗: Baseline, 4 weeks
次要结局
- Change in Hemoglobin Concentration From Baseline to Week 8(Baseline to week 8)
研究者
研究点 (1)
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