此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

A Study to Test the Non-Inferiority of Ferric Bepectate IV Against Ferric Carboxymaltose in Patients With Iron Deficiency Anemia

2026年8月18日 更新者：AFT Pharmaceuticals, Ltd.

A Multicentre, Prospective, Randomized, Active-Controlled, Open-Label, Phase III Study to Test the Non-Inferiority of Intravenous Injection of Ferric Bepectate IV Injection Compared to Ferric Carboxymaltose for Treatment of Patients With Iron Deficiency Anaemia (IDA)

The goal of this clinical trial is to see if a new intravenous iron formulation (Ferric Bepectate IV Injection) can treat adult patients with iron deficiency anemia (IDA) by increasing blood hemoglobin (Hb) as an established formulation (Ferric carboxymaltose). It will also learn about the safety of Ferric Bepectate IV Injection. The main questions it aims to answer are:

  • Does hemoglobin increase by the same amount 6 weeks after each treatment?
  • What medical problems do participants have when being treated with the drug? Researchers will compare single dose treatment plans of Ferric Bepectate to double dose treatment plans of both Ferric Bepectate and Ferric carboxymaltose.

Participants and researchers will know which drug they are being provided (open-label). Participants will visit the clinic 5 times over 6 weeks for checkups, blood tests and questionaries. The first two visits will be seven days apart and include the two doses of iron treatment.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Iron is essential for the normal functioning of a human body. Iron deficiency anemia (IDA) occurs when blood lacks adequate healthy red blood cells, preventing adequate distribution of oxygen throughout the tissue of the body.

IDA, if left uncorrected, may result in complications such as extreme fatigue, weakness, chest pain, shortness of breath, irregular heartbeats or even heart failure in some cases, in addition to reducing the overall quality of life of a patient. Iron supplementation can effectively treat IDA. An iron-rich diet is known to enhance iron levels, however supplementation is limited by the bio-availability of iron compounds. Oral iron treatment is the most common form of therapy for iron supplementation. However, oral iron supplementation is not ideal for all patients, as adverse events are common, and some patients also fail to respond. Common adverse events (AEs) include significant gastrointestinal discomfort, metallic taste and staining of teeth, resulting in patience discontinuing the treatment. Intravenous (i.v) iron therapy is regarded as a safe method to correct anemia resulting from several conditions that avoids many of the gastrointestinal AEs common with oral iron supplementation.

Ferric carboxymaltose is an established i.v iron formulation approved to treat IDA in Europe and USA. In patients with high iron need, ferric carboxymaltose requires at least two injections, at least 7 days apart. A new i.v. iron formulation has been developed, Ferric Bepectate IV Injection. Ferric Bepectate IV Injection has the potential to be dosed at higher volumes compared to other i.v. iron formulations, allowing for patients with high iron needs to only undergo a single infusion, reducing the medical burden on both the patient and the medical system, and providing a rapid improvement to IDA and associated symptoms.

The current phase 3 study aims to compare Ferric Bepectate IV Injection with two Ferric carboxymaltose formulations (comparators: Ferinject® and Injectafer®) to determine non-inferiority between the Ferric Bepectate IV Injection single dose administration and the current approved dosing for the comparators. A comparison between treatments of the change of hemoglobin (Hb) from baseline after 6 weeks will be the primary outcome. Safety of each treatment will also be assessed to determine superiority, by examining the number of adverse events in the 2 hour period following the beginning of infusion. Key secondary safety endpoints will assess the difference in volume-corrected urine iron after i.v administration, and incidence of hypophosphatemia during the 6 week follow-up period.

A two-dose administration of Ferric Bepectate IV Injection will also be assessed to compare efficacy, tolerance, and safety with the single-dose administration and the comparators.

研究类型

介入性

注册 (估计的)

1366

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 保加利亚
      • Sofia、保加利亚
        • Medical Center Levitas EOOD
        • 首席研究员：
          • Boris Krumov, MD
  • 波兰
      • Skórzewo、波兰
        • Szpital AidPort
        • 首席研究员：
          • Michal Kwiatek, MD
  • 罗马尼亚
      • Bragadiru、罗马尼亚
        • Ames Medical Research
        • 首席研究员：
          • Carastoian Nicoleta, MD
      • Bucharest、罗马尼亚
        • Colentina Clinical Hospital
        • 首席研究员：
          • Daniela Georgescu, MD
      • Bucharest、罗马尼亚
        • Sana Medical Center
        • 首席研究员：
          • Adrian Sarbu, MD
      • Cluj-Napoca、罗马尼亚
        • The Oncology Institute
        • 首席研究员：
          • Ciprian Tomuleasa, MD
  • 美国
    • Florida
      • Coral Gables、Florida、美国、33146
        • Pharmasouth Research
        • 首席研究员：
          • Francisco Quintana, MD
      • Melbourne、Florida、美国、32934
        • Trialmed Melbourne
        • 首席研究员：
          • Murray A Kimmel, MD
      • The Villages、Florida、美国、32162
        • Trialmed The Villages
        • 首席研究员：
          • Angela Okolie, MD
    • Texas
      • Dallas、Texas、美国、75246
        • M3 Wake Research
        • 首席研究员：
          • Ralph Cox, MD
      • Houston、Texas、美国、77075
        • PatientCare Clinical Research
        • 首席研究员：
          • Anibal Rossel, MD
      • San Antonio、Texas、美国、78229
        • Trialmed San Antonio
        • 首席研究员：
          • Tahira Alves, MD
      • Sugar Land、Texas、美国、77478
        • Olympus Clinical Research
        • 首席研究员：
          • Harish Thakker, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Male or female patient at least 18 years old at the time of screening
  2. Patients with general iron deficiency anaemia IDA
  3. Patients with serum ferritin levels ≤40 ng/mL inclusive
  4. Patients with haemoglobin (Hb) levels <10 g/dL
  5. Patients ≥ 35 kg body weight
  6. The patient has adequate hepatic and renal function defined as a serum aspartate aminotransferase or alanine aminotransferase level that are no more than 3 times the upper limit of the normal range, a serum bilirubin level that is no more than 2 times the upper limit of the normal range and a serum creatinine level of less than 2 mg/dL.
  7. The patient is able to understand the protocol and provides informed consent to participate in the study

Exclusion Criteria:

  1. Pregnant or breastfeeding patients
  2. Female patients not willing to use a safe method of contraception (PEARL index <1) for the full study (screening - V5).
  3. Severe physical inability, e.g., ASA physical status IV or V.
  4. Non-iron deficiency anaemia, e.g., known Vitamin B12 or folate deficiency, hemoglobinopathy, or unexplained anaemia.
  5. Patients with life-threatening anaemia, defined as Hb < 6.5 g/dL.
  6. Patient is expected to require a blood transfusion within the study period or has had a blood transfusion within the 30 days prior screening.
  7. Anticipated medical need for erythropoiesis-stimulating agents during the study period (screening - V5).
  8. Patients with hemodynamic instability due to any ongoing bleeding. Absence of ongoing bleeding will be confirmed either by decision of two independent physicians or by removal of drainage whichever occurs earlier in routine care.
  9. Patient has undergone a surgical procedure during the 30 days prior to screening, and/or is expected to undergo a surgical procedure during the study period (screening - V5).

  10. Patients with any contraindication to the investigational products, e.g.,

    1. known sensitivity to iron or an ingredient of the investigational products,
    2. significant history of systemic allergic reactions,
    3. hemochromatosis, thalassemia or TSAT >50% as indicator of iron overload,
    4. acute or chronic intoxication,
    5. infection (patient on non-prophylactic antibiotics),
    6. chronic liver disease and/or screening ALT or AST above three times the upper limit of the normal range.
    7. chronic kidney disease, defined as GFR <30 mL/min.
  11. Primary hematologic disease.
  12. Drug or alcohol abuse according to WHO definition.
  13. Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
  14. Current or previous participation in another clinical trial during the last 90 days before screening.
  15. Exclusion criteria according to SmPC of Ferric Carboxymaltose.
  16. The following concomitant treatments prescribed by a physician for non-iron deficiency anaemia (e.g., known vitamin B12 or folate deficiency), hemoglobinopathy, or unexplained anaemia are not allowed during the study and 24 weeks before screening: Erythropoiesis-stimulating agents, vitamin B12, Folic acid or other I.V. or oral iron products.
  17. Estimated life expectancy of <6 months or, for cancer patients, an Eastern Cooperative Oncology Group performance status >1

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Ferric Bepectate IV Injection single dose (US/Japan)
Single dose experimental treatment arm for USA and Japan. 50 mg iron/mL. Up to 2000 mg per dose.
药品：Ferric Bepectate IV Injection
Ferric Bepectate IV Injection 50 mg iron/mL
其他名称：
  • 铁氨酰
  • Ferric bepectate
实验性的：Ferric Bepectate IV Injection single dose (RoW)
Single dose experimental treatment arm for rest of world. 50 mg iron/mL. Up to 2000 mg per dose.
药品：Ferric Bepectate IV Injection
Ferric Bepectate IV Injection 50 mg iron/mL
其他名称：
  • 铁氨酰
  • Ferric bepectate
实验性的：Ferric Bepectate IV Injection two doses (US/Japan)
Two dose experimental treatment arm for USA and Japan. 50 mg iron/mL. Up to 1000 mg per dose.
药品：Ferric Bepectate IV Injection
Ferric Bepectate IV Injection 50 mg iron/mL
其他名称：
  • 铁氨酰
  • Ferric bepectate
实验性的：Ferric Bepectate IV Injection two doses (RoW)
Two dose experimental treatment arm for rest of world. 50 mg iron/mL. Up to 1000 mg per dose.
药品：Ferric Bepectate IV Injection
Ferric Bepectate IV Injection 50 mg iron/mL
其他名称：
  • 铁氨酰
  • Ferric bepectate
有源比较器：Injectafer (US/Japan)
Two dose ferric carboxymaltose active comparator treatment for USA and Japan. 50 mg iron/mL. Up to 750 mg per dose.
药品：Ferric Carboxymaltose Injection [Injectafer®]
Ferric carboxymaltose (Injectafer®) 50 mg iron/mL in two doses 7-9 days apart
其他名称：
  • 注射器
有源比较器：Ferinject (RoW)
Two dose ferric carboxymaltose active comparator treatment for rest of world. 50 mg iron/mL. Up to 1000 mg per dose.
药品：Ferric Carboxymaltose Injection [Ferinject]
Ferric carboxymaltose (Ferinject®) 50 mg iron/mL in two doses 7-9 days apart
其他名称：
  • 铁注射液

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in hemoglobin comparing one dose Ferric bepectate and two dose Injectafer treatment
大体时间：6 weeks
The mean change in blood hemoglobin from baseline at week 6 showing non-inferiority between the treatment groups Ferric Bepectate IV Injection (single dose) and Injectafer
6 weeks
Change in hemoglobin comparing one dose Ferric bepectate and two dose Ferinject treatment
大体时间：6 weeks
The mean change in blood hemoglobin from baseline at week 6 showing non-inferiority between the treatment groups Ferric Bepectate IV Injection (single dose) and Ferinject
6 weeks
Incidence of treatment emergent adverse events
大体时间：2 hours post infusion start
Incidence of treatment emergent adverse events (TEAE) during the 2 hours following the start of infusion
2 hours post infusion start

次要结果测量

结果测量
措施说明
大体时间
Blood hemoglobin amount
大体时间：6 weeks
Mean blood hemoglobin at weeks 1, 2, 4 and 6 timepoints. Compared between all treatment groups.
6 weeks
Hemoglobin change from baseline
大体时间：6 weeks
Mean change in blood hemoglobin from baseline to weeks 1, 2, 4 and 6.
6 weeks
Serum iron change from baseline
大体时间：6 weeks
Mean change in serum iron from baseline at weeks 1, 2, 4 and 6 timepoints. Compared between all treatment groups.
6 weeks
Serum ferritin change from baseline
大体时间：6 weeks
Mean change in serum ferritin from baseline at weeks 1, 2, 4 and 6 timepoints. Compared between all treatment groups.
6 weeks
Serum transferrin change from baseline
大体时间：6 weeks
Mean change in serum transferrin from baseline at weeks 1, 2, 4 and 6 timepoints. Compared between all treatment groups.
6 weeks
Serum transferrin saturation change from baseline
大体时间：6 weeks
Mean change in serum transferrin saturation (TSAT) from baseline at weeks 1, 2, 4 and 6 timepoints. Compared between all treatment groups.
6 weeks
Response Rate
大体时间：6 weeks
Proportion of patients with normalization (defined in WHO classification) of hemoglobin at week 6 (Response Rate).
6 weeks
Time to normalization of hemoglobin
大体时间：6 weeks
Time to normalization normalization (defined in WHO classification) of hemoglobin at week 6 (Response Rate).
6 weeks
Incidence of hypophosphatemia
大体时间：6 weeks
Incidence of hypophosphatemia (serum phosphate < 2 mg/dL) at any time during the follow-up period (baseline - week 6)
6 weeks
Volume-corrected urine iron amount
大体时间：2 hours
Pre- and post-difference of volume-corrected urine iron levels measured before and in the first urine after the end of i.v. administration, (volume corrected iron urine is defined as the ratio between urine iron and urine creatinine)
2 hours
Adverse event severity
大体时间：2 hours following infusion start
Severity of treatment emergent adverse events (TEAEs) during the 2 hours following infusion start
2 hours following infusion start
Adverse event incidence and severity
大体时间：6 weeks
Incidence and severity of TEAEs during the entire study period (screening - V5)
6 weeks
Treatment related adverse event incidence and severity
大体时间：6 weeks
Incidence and severity of AEs classified as possibly, probably or definitely related to the study drug (Treatment related adverse events; TRAE) during the study period (screening - V5)
6 weeks
Incidence of injection/infusion site reactions and hypersensitivity reactions
大体时间：2 hours following infusion start
Incidence of injection/infusion site reactions and hypersensitivity reactions
2 hours following infusion start
Change in serum phosphate
大体时间：6 weeks
Mean change in serum phosphate from baseline to week 6
6 weeks
Change in serum calcium
大体时间：6 weeks
Mean change in serum calcium from baseline to week 6
6 weeks
ECG changes
大体时间：6 weeks

Electrocardiogram (ECG) changes from baseline at week 1, 2, 4 and 6. The ECG will specifically assess the following parameters:

  • Heart Rate
  • QT interval
  • ST depression
  • T wave inversion
  • Prescence of tachycardia
  • Left ventricular hypertrophy
  • Investigator interpretation (normal, abnormal NCS, abnormal CS)
6 weeks
ECG and Hemoglobin relationship
大体时间：6 weeks
Relation between electrocardiogram (ECG) investigator interpretation (normal, abnormal NCS, abnormal CS) and hemoglobin at baseline and End of Treatment
6 weeks
Change in fatigue symptoms
大体时间：6 weeks
Change in fatigue symptoms from baseline at week 6 measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue). A final score of 0-52 is calculated, where a high score indicates better quality of life.
6 weeks

其他结果措施

结果测量
措施说明
大体时间
Pooled data hemoglobin amount
大体时间：6 weeks
Mean hemoglobin at weeks 1, 2, 4 and 6. Pooled data (USA+Japan+RoW) between study regions.
6 weeks
Pooled data change in hemoglobin
大体时间：6 weeks
Mean change in hemoglobin from baseline to weeks 1, 2, 4 and 6. Pooled data (USA+Japan+RoW) between study regions.
6 weeks
Pooled data change in serum iron
大体时间：6 weeks
Mean change in serum iron from baseline to weeks 1, 2, 4 and 6. Pooled data (USA+Japan+RoW) between study regions.
6 weeks
Pooled data change in serum ferritin
大体时间：6 weeks
Mean change in serum ferritin from baseline to weeks 1, 2, 4 and 6. Pooled data (USA+Japan+RoW) between study regions.
6 weeks
Pooled data change in serum transferrin
大体时间：6 weeks
Mean change in serum transferrin from baseline to weeks 1, 2, 4 and 6. Pooled data (USA+Japan+RoW) between study regions.
6 weeks
Pooled data change in serum transferrin saturation
大体时间：6 weeks
Mean change in serum transferrin saturation (TSAT) from baseline to weeks 1, 2, 4 and 6. Pooled data (USA+Japan+RoW) between study regions.
6 weeks
Proportion of patients requiring blood transfusion
大体时间：6 weeks
Proportion of patients who require red blood cell transfusion up to week 6. Pooled data (USA+Japan+RoW) between study regions.
6 weeks
Duration of hospital stay
大体时间：6 weeks
Duration of hospital stay (days), if applicable. Pooled data (USA+Japan+RoW) between study regions.
6 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AFT Pharmaceuticals, Ltd.

合作者

HungaroTrial

调查人员

  • 研究主任：Ioana Stanescu, Phil.Lic., MSc.、AFT Pharmaceuticals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年7月1日

研究注册日期

首次提交

2026年6月30日

首先提交符合 QC 标准的

2026年6月30日

首次发布 (实际的)

2026年7月7日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月18日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AFT-FERA-01
  • 2026-527543-17-00 (克蒂斯)
  • U1111-1343-1640 (注册表标识符：UTN)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

The results of the study may be published in a scientific journal, however individual patient data will not be used, rather data will be provided as descriptive statistics (mean, median, IQR) as required.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅