このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Non-Interventional Study of Ferretab® Comp. (Ferrous Fumarate + Folic Acid Prolonged-Release Capsules) Effects in Adult Patients With Iron Deficiency Anemia and Cardiovascular Disease (PROMETHEUS)

2026年9月14日 更新者：Alcea

A Multicenter, Non-Interventional, Prospective Study of Ferretab® Comp. (Ferrous Fumarate + Folic Acid Prolonged-Release Capsules) Effects in Adult Patients With Iron Deficiency Anemia and Cardiovascular Diseases in Real-World Clinical Practice

The goal of this observational study is to learn how well Ferretab® comp. works and how safe it is for adults with iron deficiency anemia and cardiovascular disease who are receiving treatment as part of their usual medical care. The main questions it aims to answer are:

  • Does treatment with Ferretab® comp. improve anemia?
  • Does treatment with Ferretab® comp. improve heart-related symptoms, exercise tolerance, and overall well-being?
  • What side effects do participants have while taking Ferretab® comp.?

This is a non-interventional study. Participants will receive Ferretab® comp. because their doctor has already decided to prescribe it as part of routine medical care. Ferretab® comp. is an oral medicine that contains iron (as iron fumarate) and folic acid. The study will not change their treatment.

Participants will:

  • Take Ferretab® comp. for 12 weeks as prescribed by their doctor.
  • Attend study visits at the start of treatment, after about 4 weeks, and after about 12 weeks.
  • Have routine blood tests and health assessments during the study.
  • Report any side effects and record information in a patient diary.
  • Answer questions about their symptoms, exercise tolerance, and how easy the treatment is to use.

調査の概要

状態

まだ募集していません

条件

詳細な説明

Iron deficiency anemia (IDA) is a common condition that may worsen symptoms and outcomes in people with cardiovascular diseases (CVDs). Adequate treatment of iron deficiency may improve hematologic parameters and reduce symptoms associated with anemia. This post-authorization, non-interventional study is designed to evaluate the effectiveness and safety of Ferretab® comp. in adults with IDA and concomitant cardiovascular disease treated under routine clinical practice conditions.

As this is a non-interventional study, all diagnostic and therapeutic procedures will be performed in accordance with routine clinical practice and the approved Summary of Product Characteristics. No additional diagnostic or therapeutic procedures will be performed solely for study purposes.

The study is intended to provide real-world evidence on the effectiveness, safety, and use of Ferretab® comp. in adults with iron deficiency anemia and concomitant cardiovascular disease treated in routine clinical practice.

Composition of Ferretab® comp.

Active ingredients: iron fumarate and folic acid. Each prolonged-release capsule contains 3 mini-tablets with iron fumarate and 1 mini-tablet with folic acid, which contain: iron fumarate equivalent to 50 mg of iron, folic acid - 500 mcg.

Indications:

Treatment of latent iron deficiency and iron deficiency anemia, combined with folic acid deficiency, including during pregnancy.

Ferretab® comp. is registered in:

Russia, Belarus, Kazakhstan, Kyrgyzstan, Armenia, Latvia, Lithuania, Romania, Austria, Uzbekistan

研究の種類

観察的

入学 (推定)

389

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

  • ロシア
    • Sankt-Peterburg
      • Saint Petersburg、Sankt-Peterburg、ロシア、194358
        • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
        • コンタクト：
        • 主任研究者：
          • Diana Alpenidze, MD, PhD
      • Saint Petersburg、Sankt-Peterburg、ロシア、197348
        • Surgical Clinic LLC
        • コンタクト：
        • 主任研究者：
          • Polina Ermakova, MD
      • Saint Petersburg、Sankt-Peterburg、ロシア、198328
        • Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 106"
        • コンタクト：
        • 主任研究者：
          • Vyacheslav Kubalov, MD
      • Saint Petersburg、Sankt-Peterburg、ロシア、199397
        • Astarta LLC
        • コンタクト：
        • 主任研究者：
          • Dmitriy Kositsyn, MD
    • Vsevolozhsk
      • Vsevolozhsk、Vsevolozhsk、ロシア、188643
        • Vsevolozhsk Clinical Interdistrict Hospital
        • コンタクト：
        • 主任研究者：
          • Inna Parsapina, 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

サンプリング方法

非確率サンプル

調査対象母集団

Men and women aged 18 years and older with mild to moderate IDA and CVD (coronary artery disease (CAD) and congestive heart failure (CHF) with preserved ejection fraction), who have been prescribed Ferretab® comp. as part of routine clinical practice

説明

Inclusion Criteria:

  • Male or female patients aged 18 years or older.
  • Diagnosis of mild to moderate iron deficiency anemia (IDA), defined as hemoglobin 70-129 g/L in men or 70-119 g/L in women and ferritin <30 ng/mL, with laboratory results obtained within 14 days before Visit 0.
  • Presence of at least 1 chronic CVD, defined as coronary artery disease or congestive heart failure with preserved ejection fraction (left ventricular ejection fraction ≥50%; NYHA Functional Class I-II).
  • Ability to understand the study requirements and provide written informed consent to participate in the study, including consent for the use and transfer of health information relevant to the study.
  • The physician has decided to prescribe Ferretab® comp. as IDA treatment of IDA at a dose of 2 capsules per day.
  • Signed Informed Consent Form.

Exclusion Criteria:

  • Hypersensitivity to any component of Ferretab® comp.
  • Any contraindication to the use of Ferretab® comp. as specified in the Summary of Product Characteristics.
  • Use of any other iron-containing medicinal products within 3 months prior to study enrollment (including oral iron preparations, intravenous iron formulations, or mineral/supplement products containing a therapeutic dose of iron).
  • Severe anemia (hemoglobin concentration <70 g/L).
  • Confirmed or suspected diagnosis of anemia of chronic disease.
  • Pregnancy or breastfeeding.
  • Surgery planned to be performed during the study period.
  • CVD or any other chronic disease in the stage of decompensation.
  • Congestive heart failure with reduced ejection fraction (NYHA Functional Class III-IV (see Appendix 2) and/or ejection fraction <50%).
  • Severe chronic kidney disease (Stage IV-V chronic kidney disease, or patients receiving hemodialysis or peritoneal dialysis).
  • Severe chronic liver disease (Child-Pugh Class B or C liver cirrhosis, active hepatitis, or ALT/AST >3 × the upper limit of normal).
  • Active malignancy (patients receiving chemotherapy, radiotherapy, or immunotherapy).
  • Anemias unrelated to iron deficiency, as well as other chronic hematologic disorders (thalassemia, aplastic anemia, myelodysplastic syndrome, and autoimmune hemolytic anemia).
  • Evidence of anemia of inflamation.
  • Gastrointestinal malabsorption disorders (active celiac disease, small bowel resection, short bowel syndrome, or severe flare of Crohn's disease or ulcerative colitis).
  • Recent bleeding, including gastrointestinal bleeding within 3 months before the study entry, surgery associated with blood loss within 8 weeks before the study entry, hemorrhagic stroke within 3 months before the study entry.
  • Blood transfusion within 3 months before the study entry.
  • Severe psychiatric disorders that impair the patient's ability to comply with the Protocol requirements and/or to provide valid informed consent.
  • Planned use, at the time of the study entry, of any medication or procedure listed as prohibited therapy.

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

コホートと介入

グループ/コホート
Ferretab® comp.
Adults with iron deficiency anemia (IDA) and concomitant cardiovascular disease (CVD) receiving treatment with Ferretab® comp. under routine clinical practice. Ferretab® comp. is an oral capsule containing iron fumarate (equivalent to 50 mg elemental iron) and 500 mcg folic acid.

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
Absolute change in hemoglobin level at Week 12
時間枠：From baseline (before treatment with Ferretab® comp.) to 12 weeks after treatment initiation (Visit 2)
Absolute change in hemoglobin level (g/L) from baseline (Visit 0) to Week 12 (Visit 2)
From baseline (before treatment with Ferretab® comp.) to 12 weeks after treatment initiation (Visit 2)

二次結果の測定

結果測定
メジャーの説明
時間枠
Absolute change in hemoglobin level at Week 4
時間枠：From baseline (before treatment with Ferretab® comp.) to 4 weeks after treatment initiation (Visit 1)
Absolute change in hemoglobin level (g/L) from baseline (Visit 0) to Week 4 (Visit 1)
From baseline (before treatment with Ferretab® comp.) to 4 weeks after treatment initiation (Visit 1)
Proportion of patients achieving the target hemoglobin level
時間枠：Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation
Proportion of patients achieving the target hemoglobin level (120-140 g/L in women or 130-160 g/L in men) at Week 4 (Visit 1) and Week 12 (Visit 2)
Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation
Proportion of patients achieving treatment response
時間枠：At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation
Proportion of patients achieving treatment response (an increase in hemoglobin level by 10 g/L or more at Week 4 (Visit 1) and 20 g/L or more at Week 12 (Visit 2))
At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation
Proportion of patients achieving the target ferritin level
時間枠：At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation
Proportion of patients achieving the target ferritin level (40 ng/mL or more) at Week 4 (Visit 1) and Week 12 (Visit 2).
At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation
Change in ferritin level
時間枠：From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in ferritin level from baseline (Visit 0) at Week 4 (Visit 1) and Week 12 (Visit 2).
From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Proportion of patients with an increase in hematocrit
時間枠：At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation
Proportion of patients with a 3% increase in hematocrit level (Hct) from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (Visit 2)
At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation
Change in RBC count
時間枠：From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in red blood cell (RBC) count from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (Visit 2)
From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in MCV
時間枠：From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in mean corpuscular volume (MCV) from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (Visit 2)
From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in MCH
時間枠：From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in mean corpuscular hemoglobin (MCH) from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (Visit 2)
From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in MCHC
時間枠：From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in mean corpuscular hemoglobin concentration (MCHC) from baseline (Visit 0) to Week 4 (Visit 1) and Week 12 (Visit 2)
From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Proportion of patients with a reduction in the syndrome severity
時間枠：At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation
Change in sideropenic syndrome assessed by the doctor at Week 4 (Visit 1) and Week 12 (Visit 2), expressed as the proportion of patients with a reduction in the syndrome severity.
At Week 4 (Visit 1) and Week 12 (Visit 2) after treatment initiation
Change in resting HR
時間枠：From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in resting HR from baseline (Visit 0) at Week 4 (Visit 1) and Week 12 (Visit 2).
From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in the Visual Analog Scale score for dizziness
時間枠：From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Dizziness severity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where 0 mm indicates no dizziness and 100 mm indicates the worst possible dizziness. A decrease in VAS score represents an improvement in dizziness severity.
From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in the Visual Analog Scale score for edema severity
時間枠：From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Edema severity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where 0 mm indicates no edema and 100 mm indicates the worst possible edema. A decrease in VAS score represents an improvement in edema severity.
From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in the Visual Analog Scale score for dyspnea
時間枠：From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Dyspnea severity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where 0 mm indicates no dyspnea and 100 mm indicates the worst possible dyspnea. A decrease in VAS score represents an improvement in dyspnea severity.
From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in the Visual Analog Scale score for fatigue
時間枠：From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Fatigue severity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where 0 mm indicates no fatigue and 100 mm indicates the worst possible fatigue. A decrease in VAS score represents an improvement in fatigue severity.
From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Change in the Visual Analog Scale score for exercise tolerance
時間枠：From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Exercise tolerance will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where 0 mm indicates no limitations during exercise and 100 mm indicates the greatest possible limitations during exercise. A decrease in the VAS score indicates an improvement in exercise tolerance.
From baseline (before treatment with Ferretab® comp.) to 4 weeks (Visit 1) and 12 weeks after treatment initiation (Visit 2)
Adherence to Ferretab® comp.
時間枠：During the 12-week treatment period, assessed at Weeks 4, 8, and 12
Adherence will be assessed at Weeks 4, 8, and 12 using a study-specific 4-category ordinal adherence scale included in the Patient Diary (4 = frequently missed doses; 3 = sometimes missed doses; 2 = rarely missed doses; 1 = no missed doses). Lower scores indicate better adherence. Results will be presented as n (%) in each category.
During the 12-week treatment period, assessed at Weeks 4, 8, and 12
Overall adherence to treatment with Ferretab® comp.
時間枠：During the 12-week treatment period (overall assessment at Week 12)
Overall adherence will be calculated as the median of three available assessments, the lower (worse) score if two assessments are available, or the single available score at Weeks 4, 8, and 12 by study-specific 4-category ordinal scale (4 = frequently missed doses; 3 = sometimes missed doses; 2 = rarely missed doses; 1 = no missed doses). Results will be presented as n (%) in each category.
During the 12-week treatment period (overall assessment at Week 12)

その他の成果指標

結果測定
メジャーの説明
時間枠
Convenience of use of Ferretab® comp.
時間枠：At Week 12 (Visit 2) after treatment initiation
Subjective assessment of the convenience of use of Ferretab® comp. at Visit 2
At Week 12 (Visit 2) after treatment initiation

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

Alcea

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9月1日

一次修了 (推定)

2027年5月1日

研究の完了 (推定)

2027年5月1日

試験登録日

最初に提出

2026年8月4日

QC基準を満たした最初の提出物

2026年8月4日

最初の投稿 (実際)

2026年8月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月16日

QC基準を満たした最後の更新が送信されました

2026年9月14日

最終確認日

2026年9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

  • FER-007-2025

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

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

いいえ

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。

購読する