EUCTR2009-016728-29-IE进行中（未招募）不适用
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 subjectswith non-dialysis dependent chronic kidney disease and with renal-related anaemia. - P-Monofer-CKD-02
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men and women, aged more than 18 years.
- •2. Participants diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.
- •3. Hb < 11.0 g/dL (6.80 mmol/L)
- •4. Either or both of the following iron stores indicators below target {Serum ferritin < 200 ug/l and Transferrin saturation (TfS)<20%}.
- •5. Life expectancy beyond 12 months by Principal Investigator’s judgement.
- •6. Willingness to participate after informed consent and any authorization as required by local law (e.g. Protected Health Information [PHI] for North America).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 315
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. Anaemia predominantly caused by factors other than renal
- •impairment or iron deficiency (according to Principal Investigator's
- •2. Iron overload or disturbances in utilisation of iron (e.g.
- •haemochromatosis and haemosiderosis).
- •3. 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.
- •4. Subjects with history of multiple allergies.
- •5. Decompensated liver cirrhosis or active hepatitis (Alanine
- •Aminotransferase (ALT) > 3 times upper normal limit).
- •6. Active acute or chronic infections ((assessed by clinical judgment),
- •supplied with White Blood Cells (WBC) and C-Reactive Protein (CRP)).
- •7. Rheumatoid arthritis with symptoms or signs of active joint
- •inflammation.
- •8. 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).
- •9. Extensive active bleeding necessitating blood transfusion.
- •10. Planned elective surgery during the study.
- •11. Participation in any other clinical study within 3 months prior to
- •12. Known intolerance to oral iron treatment.
- •13. Untreated B12 or folate deficiency.
- •14. I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
- •15. ESA treatment within 8 weeks prior to screening visit.
- •16. Serum ferritin > 500 µg/L.
- •17. 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.
- •18. Body weight < 30 kilograms.
研究者
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