FERRIC MALTOL for Iron deficiency

Stratification factors

• anemia status

Inclusion criteria

• {"criterion_text":"- Females ≥ 18 years\n- Mild anemia (11.0 ≤ Hb < 12 g/dl) or moderate anemia (8.0 < Hb <11 g/dl)\n- Signed informed consent form before enrollment"}

Exclusion criteria

• {"criterion_text":"- Concomitant use, or in the last month preceding the screening, of other martial drugs or supplements (supplement or drug containing iron).\n- History of psychiatric disorders that prevent the expression of informed consent or correct assumption of treatment\n- Active cancer disease except for subjects with fibroids and polyps.\n- Pregnant or nursing female patients are not eligible for this study. Pregnancy tests with a negative result must be obtained in all post-menarchal females who are not using pharmacological or barrier contraceptive methods (e.g., oral contraceptives, contraceptive patches, intrauterine devices, condoms, or diaphragms). Non-breastfeeding women are not eligible until 6 months after delivery\n- Patients participating in another experimental intervention study or receiving another experimental treatment\n- History of poor adherence to medical or patient regimes that are considered potentially unreliable and/or uncooperative, unavailable or unable to adhere to the protocol\n- Concomitant use of erythropoietin or its use within the three months prior to screening\n- Need - from the Investigator's point of view – for transfusion of concentrated erythrocytes and/or for intravenous iron infusion\n- Presence of IBD in the phase of severe activity, defined as: HBI index>16 in patients with Crohn's disease and CAI index >12 in patients with ulcerative colitis\n- Previous bariatric surgery\n- Alcohol abuse\n- Hemochromatosis and other iron overload syndromes\n- History of hereditary anemia, including thalassemia\n- History of hypersensitivity to any ingredients"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients who achieved hemoglobin normalization at the end of the 12-week treatment period (Hb ≥ 12 g/dl).","definition_or_measurement_approach":"Hemoglobin normalization defined as Hb ≥ 12 g/dl measured at end of 12-week treatment period."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients who achieved hemoglobin normalization at each timepoint","definition_or_measurement_approach":"Proportion achieving hemoglobin normalization (Hb ≥ 12 g/dl) assessed at each scheduled timepoint."}
• {"endpoint_text":"- Proportion of patients who experience adverse events (AEs) or serious adverse events (SAEs).","definition_or_measurement_approach":"Recording and reporting of adverse events and serious adverse events during treatment and follow-up per protocol safety assessments."}
• {"endpoint_text":"- Number of patients who withdraw from the study due to adverse events.","definition_or_measurement_approach":"Count of subjects who discontinued study participation because of AEs."}
• {"endpoint_text":"- Number of patients who discontinue treatment due to side effects.","definition_or_measurement_approach":"Count of subjects who stopped study treatment because of side effects."}
• {"endpoint_text":"- Proportion of patients who achieve normalization of laboratory values (sideremia, ferritin and TSAT).","definition_or_measurement_approach":"Normalization of laboratory parameters (serum iron, ferritin, transferrin saturation %) assessed per scheduled laboratory tests."}
• {"endpoint_text":"- Proportion of patients who show improvement in clinical symptoms according to the FACIT Fatigue Scale version 4.0.","definition_or_measurement_approach":"Improvement assessed by FACIT Fatigue Scale v4.0 scores at scheduled visits."}
• {"endpoint_text":"- Differences in Hemoglobin level variation from baseline between Sucrosomial® Iron and Ferric Maltol treatments.","definition_or_measurement_approach":"Comparison of change in hemoglobin from baseline between treatment arms."}
• {"endpoint_text":"- Differences in Hemoglobin level variation at each timepoint between Sucrosomial® Iron and Ferric Maltol treatments.","definition_or_measurement_approach":"Between-arm comparisons of hemoglobin change from baseline at each scheduled timepoint."}
• {"endpoint_text":"- Differences in Hemoglobin level variation from baseline between Sucrosomial® Iron and Ferric Maltol treatments in the subgroup of women with chronic inflammation (based on baseline CRP values). CRP values categorized as follows: Normal (CRP < 0.3 mg/dl); Normal or minor elevation (0.3 ≤ CRP < 1.0 mg/dl); Moderate elevation (1.0 ≤ CRP ≤ 10.0 mg/dl); Marked elevation (CRP > 10.0 mg/dl).","definition_or_measurement_approach":"Subgroup analysis of hemoglobin change by baseline CRP category as defined."}
• {"endpoint_text":"- Proportion of patients reporting refusal to take the product or discontinue due to its taste.","definition_or_measurement_approach":"Proportion of subjects who report refusal/discontinuation attributed to product taste (patient-reported)."}

Spain

Earliest CTIS Part Ii Submission Date

23-09-2025

Latest Decision Or Authorization Date

15-05-2026

Processing Time Days

234

Number Of Sites

7

Number Of Participants

146

Primary sponsor

Full Name

Pharmanutra S.p.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Third parties

• {"country":"Spain","full_name":"Komtur Pharmaceuticals Iberia S.L.","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Qualitecfarma Regulatory & Business Strategies S.L.","duties_or_roles":"1,10,11,2,5,6,8,9","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Inetsys S.L.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}