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临床试验/NCT03382275
NCT03382275已完成不适用

EXPLorative Data Collection for Patient chAracterIzation, treatmeNt Pathways and Outcomes of IRON Preparations

GWT-TUD GmbH2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2018年1月16日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
GWT-TUD GmbH
入组人数
51
试验地点
2
主要终点
Hemoglobin

研究概览

简要总结

By describing the characteristics of iron deficiency (ID) patients treated with various oral or intravenous iron formulations and their outcomes, this registry will provide the medical community with important information to support treatment decisions for their patients regarding data on effectiveness, safety, tolerability, treatment persistence, quality of life, and therapeutic costs. This will ultimately support improvements to patient care, including the long-term outcomes of patients with ID.

详细描述

Iron deficiency (ID) anaemia is a prevalent condition in Germany and other Western countries. It is a common complication in inflammatory bowel disease (IBD), cardiovascular disease including chronic heart failure, cancer, chronic kidney disease (CKD), gynaecological conditions, and others.

Anaemia has a strong impact on patient's quality of life and ability to work, and removing the condition by increasing the haemoglobin may improve QoL and other patient-related outcomes. While in certain patient groups, such as CKD, anaemia is addressed on a routine basis, in others it remains widely undertreated. For example, in IBD patients across various European countries, iron supplementation was administered in only up to 28% of individuals.

For iron supplementation aimed to replenish to body' iron stores, there are numerous oral, and intravenous preparations available.

The most convenient approach is oral administration, where Fe2+ salts are mostly used. Usually low doses between 50 - 100 mg daily are recommended, as the duodenum can only absorb 10 - 20 mg daily, and higher doses are associated with gastrointestinal side effects including diarrhoea, nausea, flatulence and gastric erosions. To reduce these common side effects, Fe3+ formulations like ferric maltol (Feraccru) have been newly introduced.

Intravenous preparations are all Fe3+ oxyhydroxides with a carbohydrate coat (iron dextran, gluconate, sucrose, carboxymaltose, or ferumexytol). These preparations are typically used second-line in patients with ID who had unsatisfactory treatment results under oral treatment. IV iron infusions have been associated with hypophosphataemia and hypersensitivity reactions. However these events depend on the preparation and are infrequent.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Female or male patients, aged at least 18 years
  • Clinical diagnosis of iron deficiency according to treating physician
  • Decision to treat with an oral or intravenous iron supplementation made by treating physician considering the indications of the respective Summary of Product Characteristics (prescribing information)
  • maintenance or newly initiated treatment (including returning quitters)
  • written informed consent

排除标准

  • patient not available for long-term documentation
  • concomitant or planned participation in a clinical trial (on iron supplementation)
  • concomitant over-the-counter iron supplementation

结局指标

主要结局

Hemoglobin

时间窗: at 3 months

serum level change compared to baseline

次要结局

  • Ferritin(2 years)
  • Hemoglobin(2 years)

研究者

发起方
GWT-TUD GmbH
申办方类型
Other
责任方
Sponsor

研究点 (2)

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