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

Pharmacosmos A/S0 个研究点目标入组 350 人开始时间: 2009年12月21日最近更新: 2015年7月10日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Pharmacosmos A/S
入组人数: 350

研究概览入排标准研究者记录与标识符相似试验

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

•Subjects with a diagnosis of Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD) associated
•with renal-related anaemia will be included if they meet all of the following criteria:
•1. Men and women, aged more than 18 years.
•2. Subjects 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•A subject will not be eligible for inclusion in this study if any of the following criteria apply:
•1. Anaemia predominantly caused by factors other than renal impairment or iron deficiency
•(according to Principal Investigator?s judgment).
•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 and hepatitis (alanine aminotransferase (ALT) > 3 times upper
•normal limit).
•6. Diagnosis of Hepatitis B and/or C confirmed by appropriate lab test.
•7. Active acute or chronic infections ((assessed by clinical judgment), supplied with White Blood
•Cells (WBC) and C - Reactive protein (CRP)).
•8. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
•9. 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).
•10. Extensive active bleeding necessitating blood transfusion.
•11. Planned elective surgery during the study.
•12. Participation in any other clinical study within 3 months prior to screening.
•13. Known intolerance to oral iron treatment.
•14. Untreated B12 or folate deficiency.
•15. I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
•16. ESA treatment within 8 weeks prior to screening visit.
•17. Serum ferritin > 500 µg/L.
•18. 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.
•19. Body weight < 30 kilograms.
•20. History of immunodeficiency, including positive HIV test result.

研究者

发起方

Pharmacosmos A/S

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