EUCTR2007-000765-37-DK进行中（未招募）不适用
A non-comparative open-label study of Iron Oligosaccharide in Chronic Kidney Disease patients with a need for parenteral iron
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Chronic Kidney Disease (CKD) patients in pre-dialysis or undergoing dialysis not currently treated with parenteral iron may be included if they meet the following criteria:
- •= 18 years of age at screening
- •Hb < 110g/L (6.8 mmol/L)
- •Serum Ferritin <800 µgram/L
- •Life expectancy beyond 12 months
- •Willingness to participate after written informed consent
- •CKD patients in pre-dialysis or undergoing dialysis willing to switch their current parenteral iron maintenance therapy to MonoFer® may be included if they meet the following criteria:
- •= 18 years of age at screening
- •Hb = 130g/L
- •Serum Ferritin <800 µgram/L
- •Life expectancy beyond 12 months
- •Willingness to participate after written informed consent
- •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
- •Non iron deficiency anaemia.
- •Iron overload or disturbances in utilisation of iron (e.g haemochromatosis, haemosiderosis).
- •Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes).
- •Patients with a history of multiple allergies.
- •Decompensated liver cirrhosis and hepatitis (ALAT > 3 times normal).
- •Acute or chronic infections (clinical judgement supplied with WBC and CRP if necessary).
- •Rheumatoid arthritis with symptoms or signs of active inflammation.
- •Pregnancy and nursing. To avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception.
- •Active bleeding.
- •Planned elective surgery during the study where significant blood loss is expected.
- •Participation in any other clinical trial where the study drug has not passed five half-lives prior to screening.
研究者
相似试验
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A non-comparative open-label study of Iron Oligosaccharide in CHF patients with iron deficiency (either absolute or functional) anaemia and a need for parenteral iron.Patients with anaemia and who have a need for parenteral iron due to either absolute or functional iron deficiency anaemia will be included. Patients may receive concomitant Erythropoeisis Stimulating Agents treatment according to hospital standards but this is not a requirement for participation.Patients previous treated with parenteral iron therapy but still needing further Iron who fullfils the inclusion criteria may be switched from an existing parenteral iron treatment.MedDRA version: 9.1Level: LLTClassification code 10002062Term: Anaemia iron deficiencyMedDRA version: 9.1Level: LLTClassification code 10010684Term: Congestive heart failureEUCTR2007-000764-25-DKPharmacosmos A/S
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3 期
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