Benefit of Liposomal iron in children with functional iron deficiency anemia in chronic kidney disease

Efficacy and safety of oral liposomal iron in children with functional iron deficiency anemia and chronic kidney disease - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097569

Enrollment

Registered

2025-11-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Health Condition 1: N189- Chronic kidney disease, unspecified

Interventions

Intervention1: oral liposomal iron: Eligible patients will be provided with oral liposomal iron with the dose being decided as per weight band Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: Children with CKD stages 2 to 5 Patients in the age group of 3 years to 18 years Anemia as defined by WHO criteria Functional iron deficiency as defined by KDIGO Not receiving dialysis Erythropoiesis stimulating agent na ve or on stable dose of ESA

Exclusion criteria

Exclusion criteria: Known hemoglobinopathies Baseline hemoglobin than 7 g per dl Known malabsorption disorders Active infection Kidney allograft recipients Patients who received packed red cell transfusion or intravenous iron supplementation in last 4 weeks Patients with parathormone levels more than 700 pg per ml Refusal of consent

Design outcomes

Primary

Measure	Time frame
To determine the increase in hemoglobin levels in children aged 3 to 18 years with chronic kidney disease not on dialysis with anemia due to functional iron deficiency - transferrin saturation less than 20 percentage and serum ferritin more than 100 to 200 microgram per l who are supplemented with oral liposomal iron at a dose of 29 mg/day for children weighing less than 25 kg and 58 mg per day for more than or equal to 25 kg weight for a duration of 12 weeks Primary Objective Timepoint: 12 weeks	—

Measure

Time frame

To determine the increase in hemoglobin levels in children aged 3 to 18 years with chronic kidney disease not on dialysis with anemia due to functional iron deficiency - transferrin saturation less than 20 percentage and serum ferritin more than 100 to 200 microgram per l who are supplemented with oral liposomal iron at a dose of 29 mg/day for children weighing less than 25 kg and 58 mg per day for more than or equal to 25 kg weight for a duration of 12 weeks Primary Objective Timepoint: 12 weeks

—

Secondary

Measure	Time frame
Efficacy parameters Increase in transferrin saturation from baseline Increase in serum ferritin from baseline Change in hepcidin levels from baseline Change in reticulocyte hemoglobin equivalent and hypochromic reticulocytes Timepoint: 12 weeks;Safety Proportion of children with adverse events, including Serum ferritin more than 700 g per l Gastrointestinal side effects any of these -abdominal pain, nausea, diarrhea, constipation Timepoint: 12 weeks	—

Measure

Time frame

Efficacy parameters Increase in transferrin saturation from baseline Increase in serum ferritin from baseline Change in hepcidin levels from baseline Change in reticulocyte hemoglobin equivalent and hypochromic reticulocytes Timepoint: 12 weeks;Safety Proportion of children with adverse events, including Serum ferritin more than 700 g per l Gastrointestinal side effects any of these -abdominal pain, nausea, diarrhea, constipation Timepoint: 12 weeks

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Countries

India

Contacts

Public ContactVishnu Dev P M

ALL INDIA INSTITUTE OF MEDICAL SCIENCES , NEW DELHI

drpankajhari@gmail.com9560701175

Outcome results

None listed

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