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临床试验/CTRI/2024/07/071219
CTRI/2024/07/071219尚未招募不适用

Safety, efficacy, cost analysis and acceptability of Intravenous Ferric Carboxymaltose for treatment of Iron deficiency anemia in a tertiary care centre

AIIMS Guwahati1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
57
试验地点
1
主要终点
Cost analysis of Intravenous Ferric Carboxymaltose for treatment of Iron deficiency anemia in a tertiary care centre

研究概览

简要总结

Iron deficiency remains the leading cause of anemia worldwide with significant negative impact on health.Iron repletion options available are oral and  Intravenous(IV) formulations.Though oral iron is considered the first line of therapy for treatment of Iron deficiency anemia(IDA) due to its low cost,good safety profile and ease of administration it’s absorption is affected by several factors and incidence of gastrointestinal side effects can lead to lack of adherence to therapy and poor efficacy.This has led to emergence of intravenous iron therapy which is clearly superior to oral iron with higher increment of hemoglobin levels and rapid replenishment of iron stores.Ferric Carboxymaltose (FCM) is a novel non dextran intravenous iron form which has been approved for patients with iron deficiency who have had inadequate response to oral iron therapy,intolerance to oral iron or non dialysis dependent chronic kidney disease.The safety and efficacy of using FCM in treatment of iron deficiency anemia has been demonstrated in several clinical trials.It has been shown to be non inferior to other intravenous iron formulations with a good safety profile.In spite of it’s efficacy it has been seen that FCM’s acceptability is low and use is limited. No such study has been done in this part of the country.It is not supplied under any national programme. The project aims to quantify efficacy and cost to study its feasibility and find reasons for it’s low acceptability.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients ≥ 18 years of age with confirmed diagnosis of Iron deficiency anemia
  • Those who have given consent.

排除标准

  • Patients with previous history of hypersensitivity reaction to any of the parenteral iron products
  • Pregnant females
  • Patients with concurrent Vitamin B12 deficiency.

结局指标

主要结局

Cost analysis of Intravenous Ferric Carboxymaltose for treatment of Iron deficiency anemia in a tertiary care centre

时间窗: Data collection at 2 time points: | 1) At the time of diagnosis | 2) Assessment of therapeutic response 1 month after the first dose of Injection Ferric Carboxymaltose

次要结局

  • Safety, efficacy and acceptability of Intravenous Ferric Carboxymaltose for treatment of Iron deficiency anemia in a tertiary care centre(Data collection at 2 time points:)

研究者

发起方
AIIMS Guwahati
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Rituparna Chetia

All India Institute of Medical Sciences (AIIMS),Guwahati

研究点 (1)

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