DRKS00010766已完成4 期
A randomized, double-blind comparative study comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for iron substitution in iron-deficiency anemia - HOMe aFers 1
niversität des Saarlandes0 个研究点目标入组 26 人开始时间: 2016年6月27日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Female
入选标准
- •Written informed consent,
- •gynecological blood losses,
- •Age = 18 years,
- •iron deficiency anemia,
- •Hemoglobin < 12,0 g/dl,
- •Serum-Ferritin = 100 ng/ml or Serum-Ferritin = 300 ng/ml and Transferrin-saturation = 30 %,
- •Intolerance to or inefficacy of an oral iron supplement
- •eGFR > 15 ml/min/1.73 m²
排除标准
- •Known hypersensitivity to MonoFer® or FERINJECT®,
- •severe, known hypersensitivity to other intravenous iron preparations,
- •Plasma Phosphate < 2.5 mg/dl at screening,
- •Hemochromatosis,
- •Untreated hyperparathyreoidism,
- •Renal replacement therapy/kidney transplantation,
- •Active malignant disease, disease-free survival for less than 5 years,
- •Intravenous iron administration within the last 30 days,
- •Treatment with erythropoietin or erythropoietin-stimulating agents, transfusion of red blood cells, radiotherapy or chemotherapy within the last 60 days,
- •Surgery under anesthetic within the last 10 days,
- •Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 fold above levels in healthy individuals,
- •Acute febrile infections within the last 7 days,
- •Chronic inflammatory diseases requiring a systemic antiinflammatory treatment,
- •self-reported severe asthma or eczema,
- •presence of further relative contraindications (any allergy, any immunologic or inflammatory diseases, history of atopic allergies), which, according the assessment of the investigator, appear to be a contraindication for the treatment with one of the investigational medicinal products,
- •pregnancy,
- •women of childbearing potential without an effective method of contraception,
- •lactating women,
- •Present alcohol or drug dependency,
- •Patients with a history of a psychological illness or seizures,
- •Non-compliance or administration of any investigational drug within 30 days preceding the study start;
研究者
相似试验
已完成
4 期
To compare the efficacy and safety of the combined application of topical diltiazem and lignocaine gel as compared to either drugs alone in the management of anal fissuresCTRI/2008/091/000280Troikaa Pharmaceuticals Limited75
进行中（未招募）
1 期
A clinical study to assess the efficacy of Orelvo (voclosporin) compared with placebo in achieving renal response after 24 weeks of therapy in subjects with active lupus nephritis (LN)upus NephritisMedDRA version: 21.1 Level: PT Classification code 10025140 Term: Lupus nephritis System Organ Class: 10038359 - Renal and urinary disordersEUCTR2016-004045-81-PLAurinia Pharmaceuticals, Inc.324
进行中（未招募）
1 期
A clinical study to assess the efficacy of Orelvo (voclosporin) compared with placebo in achieving renal response after 24 weeks of therapy in subjects with active lupus nephritis (LN)Active Lupus NephritisMedDRA version: 19.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2016-004045-81-ESAurinia Pharmaceuticals, Inc.324
已完成
3 期
A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Orelvo (voclosporin) (23.7 mg Twice Daily) with Placebo in Achieving Renal Response in Subjects with Active Lupus NephritisActive Lupus Nephritis10003816NL-OMON49474Worldwide Clinical Trials4
进行中（未招募）
1 期
Clinical study comparing the efficacy in the achievement of the remission (measured as reduction of proteinuria) and safety of two different doses of voclosporin and non active drug (placebo) in patients suffering from active lupus nephritisEUCTR2012-003364-51-BGAurinia Pharmaceuticals Inc.258