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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

1366

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Florida
      • Coral Gables、Florida、アメリカ、33146
        • Pharmasouth Research
        • 主任研究者：
          • Francisco Quintana, MD
      • Melbourne、Florida、アメリカ、32934
        • Trialmed Melbourne
        • 主任研究者：
          • Murray A Kimmel, MD
      • The Villages、Florida、アメリカ、32162
        • Trialmed The Villages
        • 主任研究者：
          • Angela Okolie, MD
    • Texas
      • Dallas、Texas、アメリカ、75246
        • M3 Wake Research
        • 主任研究者：
          • Ralph Cox, MD
      • Houston、Texas、アメリカ、77075
        • PatientCare Clinical Research
        • 主任研究者：
          • Anibal Rossel, MD
      • San Antonio、Texas、アメリカ、78229
        • Trialmed San Antonio
        • 主任研究者：
          • Tahira Alves, MD
      • Sugar Land、Texas、アメリカ、77478
        • Olympus Clinical Research
        • 主任研究者：
          • Harish Thakker, MD
  • ブルガリア
      • Sofia、ブルガリア
        • Medical Center Levitas EOOD
        • 主任研究者：
          • Boris Krumov, MD
  • ポーランド
      • Skórzewo、ポーランド
        • Szpital AidPort
        • 主任研究者：
          • Michal Kwiatek, MD
  • ルーマニア
      • Bragadiru、ルーマニア
        • Ames Medical Research
        • 主任研究者：
          • Carastoian Nicoleta, MD
      • Bucharest、ルーマニア
        • Colentina Clinical Hospital
        • 主任研究者：
          • Daniela Georgescu, MD
      • Bucharest、ルーマニア
        • Sana Medical Center
        • 主任研究者：
          • Adrian Sarbu, MD
      • Cluj-Napoca、ルーマニア
        • The Oncology Institute
        • 主任研究者：
          • Ciprian Tomuleasa, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：Ferric Bepectate IV Injection
Ferric Bepectate IV Injection 50 mg iron/mL
他の名前：
  • フェラミル
  • Ferric bepectate
実験的：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.
薬：Ferric Bepectate IV Injection
Ferric Bepectate IV Injection 50 mg iron/mL
他の名前：
  • フェラミル
  • Ferric bepectate
実験的：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.
薬：Ferric Bepectate IV Injection
Ferric Bepectate IV Injection 50 mg iron/mL
他の名前：
  • フェラミル
  • Ferric bepectate
実験的：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.
薬：Ferric Bepectate IV Injection
Ferric Bepectate IV Injection 50 mg iron/mL
他の名前：
  • フェラミル
  • Ferric bepectate
アクティブコンパレータ：Injectafer (US/Japan)
Two dose ferric carboxymaltose active comparator treatment for USA and Japan. 50 mg iron/mL. Up to 750 mg per dose.
薬：Ferric Carboxymaltose Injection [Injectafer®]
Ferric carboxymaltose (Injectafer®) 50 mg iron/mL in two doses 7-9 days apart
他の名前：
  • インジェクタファー
アクティブコンパレータ：Ferinject (RoW)
Two dose ferric carboxymaltose active comparator treatment for rest of world. 50 mg iron/mL. Up to 1000 mg per dose.
薬：Ferric Carboxymaltose Injection [Ferinject]
Ferric carboxymaltose (Ferinject®) 50 mg iron/mL in two doses 7-9 days apart
他の名前：
  • フェリンジェクト

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in hemoglobin comparing one dose Ferric bepectate and two dose Injectafer treatment
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Blood hemoglobin amount
時間枠：6 weeks
Mean blood hemoglobin at weeks 1, 2, 4 and 6 timepoints. Compared between all treatment groups.
6 weeks
Hemoglobin change from baseline
時間枠：6 weeks
Mean change in blood hemoglobin from baseline to weeks 1, 2, 4 and 6.
6 weeks
Serum iron change from baseline
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：6 weeks
Time to normalization normalization (defined in WHO classification) of hemoglobin at week 6 (Response Rate).
6 weeks
Incidence of hypophosphatemia
時間枠：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
時間枠：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
時間枠：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
時間枠：6 weeks
Incidence and severity of TEAEs during the entire study period (screening - V5)
6 weeks
Treatment related adverse event incidence and severity
時間枠：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
時間枠：2 hours following infusion start
Incidence of injection/infusion site reactions and hypersensitivity reactions
2 hours following infusion start
Change in serum phosphate
時間枠：6 weeks
Mean change in serum phosphate from baseline to week 6
6 weeks
Change in serum calcium
時間枠：6 weeks
Mean change in serum calcium from baseline to week 6
6 weeks
ECG changes
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Pooled data hemoglobin amount
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：6 weeks
Duration of hospital stay (days), if applicable. Pooled data (USA+Japan+RoW) between study regions.
6 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

AFT Pharmaceuticals, Ltd.

協力者

HungaroTrial

捜査官

  • スタディディレクター：Ioana Stanescu, Phil.Lic., MSc.、AFT Pharmaceuticals

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年12月1日

一次修了 (推定)

2028年6月1日

研究の完了 (推定)

2028年7月1日

試験登録日

最初に提出

2026年6月30日

QC基準を満たした最初の提出物

2026年6月30日

最初の投稿 (実際)

2026年7月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月20日

QC基準を満たした最後の更新が送信されました

2026年8月18日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • AFT-FERA-01
  • 2026-527543-17-00 (Ctis)
  • U1111-1343-1640 (レジストリ識別子：UTN)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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