A Study to Test the Non-Inferiority of Ferric Bepectate IV Against Ferric Carboxymaltose in Patients With Iron Deficiency Anemia
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Phillip Aitken, PhD
- Número de telefone: +6494880232
- E-mail: phillip.aitken@aftpharm.com
Locais de estudo
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Sofia, Bulgária
- Medical Center Levitas EOOD
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Investigador principal:
- Boris Krumov, MD
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Florida
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Coral Gables, Florida, Estados Unidos, 33146
- Pharmasouth Research
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Investigador principal:
- Francisco Quintana, MD
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Melbourne, Florida, Estados Unidos, 32934
- Trialmed Melbourne
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Investigador principal:
- Murray A Kimmel, MD
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The Villages, Florida, Estados Unidos, 32162
- Trialmed The Villages
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Investigador principal:
- Angela Okolie, MD
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Texas
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Dallas, Texas, Estados Unidos, 75246
- M3 Wake Research
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Investigador principal:
- Ralph Cox, MD
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Houston, Texas, Estados Unidos, 77075
- PatientCare Clinical Research
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Investigador principal:
- Anibal Rossel, MD
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San Antonio, Texas, Estados Unidos, 78229
- Trialmed San Antonio
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Investigador principal:
- Tahira Alves, MD
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Sugar Land, Texas, Estados Unidos, 77478
- Olympus Clinical Research
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Investigador principal:
- Harish Thakker, MD
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Skórzewo, Polônia
- Szpital AidPort
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Investigador principal:
- Michal Kwiatek, MD
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Bragadiru, Romênia
- Ames Medical Research
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Investigador principal:
- Carastoian Nicoleta, MD
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Bucharest, Romênia
- Colentina Clinical Hospital
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Investigador principal:
- Daniela Georgescu, MD
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Bucharest, Romênia
- Sana Medical Center
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Investigador principal:
- Adrian Sarbu, MD
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Cluj-Napoca, Romênia
- The Oncology Institute
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Investigador principal:
- Ciprian Tomuleasa, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Male or female patient at least 18 years old at the time of screening
- Patients with general iron deficiency anaemia IDA
- Patients with serum ferritin levels ≤40 ng/mL inclusive
- Patients with haemoglobin (Hb) levels <10 g/dL
- Patients ≥ 35 kg body weight
- 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.
- The patient is able to understand the protocol and provides informed consent to participate in the study
Exclusion Criteria:
- Pregnant or breastfeeding patients
- Female patients not willing to use a safe method of contraception (PEARL index <1) for the full study (screening - V5).
- Severe physical inability, e.g., ASA physical status IV or V.
- Non-iron deficiency anaemia, e.g., known Vitamin B12 or folate deficiency, hemoglobinopathy, or unexplained anaemia.
- Patients with life-threatening anaemia, defined as Hb < 6.5 g/dL.
- Patient is expected to require a blood transfusion within the study period or has had a blood transfusion within the 30 days prior screening.
- Anticipated medical need for erythropoiesis-stimulating agents during the study period (screening - V5).
- 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.
- 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).
Patients with any contraindication to the investigational products, e.g.,
- known sensitivity to iron or an ingredient of the investigational products,
- significant history of systemic allergic reactions,
- hemochromatosis, thalassemia or TSAT >50% as indicator of iron overload,
- acute or chronic intoxication,
- infection (patient on non-prophylactic antibiotics),
- chronic liver disease and/or screening ALT or AST above three times the upper limit of the normal range.
- chronic kidney disease, defined as GFR <30 mL/min.
- Primary hematologic disease.
- Drug or alcohol abuse according to WHO definition.
- Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
- Current or previous participation in another clinical trial during the last 90 days before screening.
- Exclusion criteria according to SmPC of Ferric Carboxymaltose.
- 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.
- Estimated life expectancy of <6 months or, for cancer patients, an Eastern Cooperative Oncology Group performance status >1
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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.
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Ferric Bepectate IV Injection 50 mg iron/mL
Outros nomes:
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Experimental: 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.
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Ferric Bepectate IV Injection 50 mg iron/mL
Outros nomes:
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Experimental: 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.
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Ferric Bepectate IV Injection 50 mg iron/mL
Outros nomes:
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Experimental: 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.
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Ferric Bepectate IV Injection 50 mg iron/mL
Outros nomes:
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Comparador Ativo: Injectafer (US/Japan)
Two dose ferric carboxymaltose active comparator treatment for USA and Japan.
50 mg iron/mL.
Up to 750 mg per dose.
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Ferric carboxymaltose (Injectafer®) 50 mg iron/mL in two doses 7-9 days apart
Outros nomes:
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Comparador Ativo: Ferinject (RoW)
Two dose ferric carboxymaltose active comparator treatment for rest of world.
50 mg iron/mL.
Up to 1000 mg per dose.
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Ferric carboxymaltose (Ferinject®) 50 mg iron/mL in two doses 7-9 days apart
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in hemoglobin comparing one dose Ferric bepectate and two dose Injectafer treatment
Prazo: 6 weeks
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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
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6 weeks
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Change in hemoglobin comparing one dose Ferric bepectate and two dose Ferinject treatment
Prazo: 6 weeks
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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
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6 weeks
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Incidence of treatment emergent adverse events
Prazo: 2 hours post infusion start
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Incidence of treatment emergent adverse events (TEAE) during the 2 hours following the start of infusion
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2 hours post infusion start
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Blood hemoglobin amount
Prazo: 6 weeks
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Mean blood hemoglobin at weeks 1, 2, 4 and 6 timepoints.
Compared between all treatment groups.
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6 weeks
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Hemoglobin change from baseline
Prazo: 6 weeks
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Mean change in blood hemoglobin from baseline to weeks 1, 2, 4 and 6.
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6 weeks
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Serum iron change from baseline
Prazo: 6 weeks
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Mean change in serum iron from baseline at weeks 1, 2, 4 and 6 timepoints.
Compared between all treatment groups.
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6 weeks
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Serum ferritin change from baseline
Prazo: 6 weeks
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Mean change in serum ferritin from baseline at weeks 1, 2, 4 and 6 timepoints.
Compared between all treatment groups.
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6 weeks
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Serum transferrin change from baseline
Prazo: 6 weeks
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Mean change in serum transferrin from baseline at weeks 1, 2, 4 and 6 timepoints.
Compared between all treatment groups.
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6 weeks
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Serum transferrin saturation change from baseline
Prazo: 6 weeks
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Mean change in serum transferrin saturation (TSAT) from baseline at weeks 1, 2, 4 and 6 timepoints.
Compared between all treatment groups.
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6 weeks
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Response Rate
Prazo: 6 weeks
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Proportion of patients with normalization (defined in WHO classification) of hemoglobin at week 6 (Response Rate).
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6 weeks
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Time to normalization of hemoglobin
Prazo: 6 weeks
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Time to normalization normalization (defined in WHO classification) of hemoglobin at week 6 (Response Rate).
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6 weeks
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Incidence of hypophosphatemia
Prazo: 6 weeks
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Incidence of hypophosphatemia (serum phosphate < 2 mg/dL) at any time during the follow-up period (baseline - week 6)
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6 weeks
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Volume-corrected urine iron amount
Prazo: 2 hours
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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)
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2 hours
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Adverse event severity
Prazo: 2 hours following infusion start
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Severity of treatment emergent adverse events (TEAEs) during the 2 hours following infusion start
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2 hours following infusion start
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Adverse event incidence and severity
Prazo: 6 weeks
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Incidence and severity of TEAEs during the entire study period (screening - V5)
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6 weeks
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Treatment related adverse event incidence and severity
Prazo: 6 weeks
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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)
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6 weeks
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Incidence of injection/infusion site reactions and hypersensitivity reactions
Prazo: 2 hours following infusion start
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Incidence of injection/infusion site reactions and hypersensitivity reactions
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2 hours following infusion start
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Change in serum phosphate
Prazo: 6 weeks
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Mean change in serum phosphate from baseline to week 6
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6 weeks
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Change in serum calcium
Prazo: 6 weeks
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Mean change in serum calcium from baseline to week 6
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6 weeks
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ECG changes
Prazo: 6 weeks
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Electrocardiogram (ECG) changes from baseline at week 1, 2, 4 and 6. The ECG will specifically assess the following parameters:
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6 weeks
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ECG and Hemoglobin relationship
Prazo: 6 weeks
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Relation between electrocardiogram (ECG) investigator interpretation (normal, abnormal NCS, abnormal CS) and hemoglobin at baseline and End of Treatment
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6 weeks
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Change in fatigue symptoms
Prazo: 6 weeks
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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.
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6 weeks
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pooled data hemoglobin amount
Prazo: 6 weeks
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Mean hemoglobin at weeks 1, 2, 4 and 6.
Pooled data (USA+Japan+RoW) between study regions.
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6 weeks
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Pooled data change in hemoglobin
Prazo: 6 weeks
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Mean change in hemoglobin from baseline to weeks 1, 2, 4 and 6.
Pooled data (USA+Japan+RoW) between study regions.
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6 weeks
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Pooled data change in serum iron
Prazo: 6 weeks
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Mean change in serum iron from baseline to weeks 1, 2, 4 and 6.
Pooled data (USA+Japan+RoW) between study regions.
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6 weeks
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Pooled data change in serum ferritin
Prazo: 6 weeks
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Mean change in serum ferritin from baseline to weeks 1, 2, 4 and 6.
Pooled data (USA+Japan+RoW) between study regions.
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6 weeks
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Pooled data change in serum transferrin
Prazo: 6 weeks
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Mean change in serum transferrin from baseline to weeks 1, 2, 4 and 6.
Pooled data (USA+Japan+RoW) between study regions.
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6 weeks
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Pooled data change in serum transferrin saturation
Prazo: 6 weeks
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Mean change in serum transferrin saturation (TSAT) from baseline to weeks 1, 2, 4 and 6.
Pooled data (USA+Japan+RoW) between study regions.
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6 weeks
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Proportion of patients requiring blood transfusion
Prazo: 6 weeks
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Proportion of patients who require red blood cell transfusion up to week 6.
Pooled data (USA+Japan+RoW) between study regions.
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6 weeks
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Duration of hospital stay
Prazo: 6 weeks
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Duration of hospital stay (days), if applicable.
Pooled data (USA+Japan+RoW) between study regions.
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6 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Ioana Stanescu, Phil.Lic., MSc., AFT Pharmaceuticals
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AFT-FERA-01
- 2026-527543-17-00 (Ctis)
- U1111-1343-1640 (Identificador de registro: UTN)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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