Health Condition 1: D509- Iron deficiency anemia, unspecified Health Condition 2: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Ferric derisomaltose: Iv iron preparations
Control Intervention1: ferric carboxymaltose: Iv iron preparations
Sponsors
Dr Rajshree paladi
Eligibility
Inclusion criteria
Inclusion criteria: Females aged 18 to 65 years. Diagnosed with iron deficiency anemia (Hb less than 12 gperdL). Serum ferritin less than 100 ngpermL or TSAT less than 20percent. Eligible for IV iron therapy due to intolerance, non-compliance, or failure of oral iron. Able to provide written informed consent.
Exclusion criteria
Exclusion criteria: Known hypersensitivity to any of the study medications. Anemia due to non-iron deficiency causes (e.g., B12 or folate deficiency, hemolytic anemia). Active infection, liver disease, or severe renal impairment (eGFR less than 30 mLperminper1.73 m2). Serum phosphate less than2.5 mgperdL at baseline. Prior IV iron administration within the past 8 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: Mean change in hemoglobin level from baseline to 8 weeks. Timepoint: Primary Outcome: Mean change in hemoglobin level from baseline to 8 weeks. Secondary Outcomes: Change in serum ferritin and TSAT from baseline to 8 weeks. Incidence of hypophosphatemia (serum phosphate less than 2.5 mgperdL). Change in serum phosphate and FGF23 (optional exploratory outcome). Incidence and severity of adverse drug reactions | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes: Change in serum ferritin and TSAT from baseline to 8 weeks. Incidence of hypophosphatemia (serum phosphate less than 2.5 mgperdL). Change in serum phosphate and FGF23 (optional exploratory outcome). Incidence and severity of adverse drug reactions Timepoint: | — |
Countries
India
Contacts
Public ContactDr Shazia Sumran
Khaja Bandanawaz University (KBNU).
Outcome results
None listed