A Non-Comparative Open-Label Study of Iron Oligosaccharide in Chronic Kidney Disease Patients With a Need for Parenteral Iron
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Adverse events (AE) (Number and type of AE)
研究概览
简要总结
The purpose of this study is to determine the safety profile of iron oligosaccharide in patients with chronic kidney disease with a need for parenteral iron.
详细描述
Iron dextrans have been marketed for more than 50 years and the compiled preclinical and clinical experience with iron dextrans in general is well established. Pharmacosmos A/S already markets the iron dextran CosmoFer® worldwide, except in the US where the product is named INFeD®. A new iron oligosaccharide has been manufactured by Pharmacosmos A/S and it is a further development of CosmoFer® where ferric hydroxide has been combined with low molecular weight oligosaccharides in a relatively strong complex. This iron carbohydrate complex builds on the well established efficacy and safety profile of existing iron dextran but with a significantly reduced anaphylactic potential.
In order to ensure that iron oligosaccharide will not lead to unexpected adverse events the existing clinical information on iron dextrans in general needs to be supplied with clinical safety data from a limited number of relevant patients exposed to iron oligosaccharide in open label non-comparator studies.
The primary objective of the present study is to obtain such safety reassurance with the use of iron oligosaccharide given either as repeated IV boluses or as total dose infusion for correction/maintenance therapy of anaemia in patients with chronic kidney disease with a need for parenteral iron due to either absolute or functional iron deficiency anaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Chronic kidney disease 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 < 110 g/L (6.8 mmol/L)
- •Serum ferritin < 800 µgram/L
- •Life expectancy beyond 12 months
- •Willingness to participate after written informed consent
- •Chronic kidney disease patients in pre-dialysis or undergoing dialysis willing to switch their current parenteral iron maintenance therapy to iron oligosaccharide may be included if they meet the following criteria:
- •≥ 18 years of age at screening
- •Hb ≤ 130 g/L
- •Serum ferritin > 200 µgram/L but < 800 µgram/L
- •Life expectancy beyond 12 months
- •Willingness to participate after written informed consent
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 (alanine aminotransferase > 3 times normal).
- •Acute or chronic infections
- •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 within three months prior to screening
研究组 & 干预措施
1
Iron oligosaccharide
干预措施: Iron oligosaccharide (Drug)
结局指标
主要结局
Adverse events (AE) (Number and type of AE)
时间窗: Eight weeks after enrollment
Serious adverse events (SAEs)
时间窗: Eight weeks after enrollment
Clinical laboratory tests (biochemistry, haematology)
时间窗: At every visit
Physical examination
时间窗: At screening visit and at end of study
Vital signs
时间窗: At every visit
次要结局
- Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels(At every visit)