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Efficacy of different doses Intravenous ferric derisomaltose in women of childbearing age with iron deficiency anemia

Efficacy of different doses Intravenous ferric derisomaltose in women of childbearing age with iron deficiency anemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064994
Enrollment
Unknown
Registered
2022-10-25
Start date
2022-10-27
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron deficiency anemia

Interventions

Group 1:Iron Isomaltose 1000 mg
Group 2:Iron requirements were calculated according to Ganzoni's formula and iron isomaltose was used in full doses

Sponsors

Shanghai Baoshan Integrated Traditional Chinese and Western Medicine Hospital (Baoshan Branch of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 49 Years

Inclusion criteria

Inclusion criteria: 1. Women of childbearing age who are >= 18 years old and = 50 kg; 3. IDA caused by different etiologies; 4. Calculated according to the Ganzoni formula, patients whose actual iron supplement requirement is > 1000 mg; 5. Oral iron intolerance or non-response, or patients with low hemoglobin during screening who need rapid iron supplementation; 6.Hb <= 110 g/L; 7. SF < 100 ng/ml; 8. TSAT < 15%.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant, breastfeeding or planning to become pregnant; 2. It is known that severe hypersensitivity reactions have occurred during the application of other parenteral iron agents; 3. Non-iron deficiency anemia (such as hemolytic anemia); 4. Decompensated cirrhosis or active hepatitis (alanine aminotransferase > 3 times the upper limit of normal value); 5. Patients who underwent blood transfusion throughout the study period.

Design outcomes

Primary

MeasureTime frame
hemoglobin;Serum ferritin;TSAT;

Countries

China

Contacts

Public ContactMeihong Luo

Shanghai Baoshan Integrated Traditional Chinese and Western Medicine Hospital (Baoshan Branch of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)

Lmh021009@163.com+86 13585703963

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026