Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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)

14. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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

Studietype

Observasjonsmessig

Registrering (Antatt)

389

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Russland
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russland, 194358
        • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
        • Ta kontakt med:
        • Hovedetterforsker:
          • Diana Alpenidze, MD, PhD
      • Saint Petersburg, Sankt-Peterburg, Russland, 197348
        • Surgical Clinic LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Polina Ermakova, MD
      • Saint Petersburg, Sankt-Peterburg, Russland, 198328
        • Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 106"
        • Ta kontakt med:
        • Hovedetterforsker:
          • Vyacheslav Kubalov, MD
      • Saint Petersburg, Sankt-Peterburg, Russland, 199397
        • Astarta LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dmitriy Kositsyn, MD
    • Vsevolozhsk
      • Vsevolozhsk, Vsevolozhsk, Russland, 188643
        • Vsevolozhsk Clinical Interdistrict Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Inna Parsapina, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Absolute change in hemoglobin level at Week 12
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Absolute change in hemoglobin level at Week 4
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Convenience of use of Ferretab® comp.
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alcea

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. mai 2027

Studiet fullført (Antatt)

1. mai 2027

Datoer for studieregistrering

Først innsendt

4. august 2026

Først innsendt som oppfylte QC-kriteriene

4. august 2026

Først lagt ut (Faktiske)

7. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FER-007-2025

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere