Comparing the effectiveness and safety of oral liposomal iron and conventional iron in treating anemia in children with chronic kidney disease (stages 3–5)

Efficacy and safety of oral liposomal Iron versus conventional oral Iron In children with chronic kidney disease stage 3-5 with anemia- an open labelled randomised controlled. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062336

Enrollment

Registered

2024-02-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)

Interventions

Intervention1: Oral liposomal iron: Children with CKD stages 3–5 who have anemia will be given oral liposomal iron in the intervention arm, and a rise in hemoglobin level will be assessed at the end o

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: Less than or equal to 14 years 2. Chronic kidney disease not on hemodialysis 3. Anemia based on age and gender-specific values (KDIGO 2012) 4. Normal B12 and folate levels 5. Written informed consent

Exclusion criteria

Exclusion criteria: 1. CKD on IV iron therapy 2. Hyperparathyroidism (iPTH >700 pg/mL) 3. Known haematological disorders 4. Bleeding or blood transfusions in the last 3 months

Design outcomes

Primary

Measure	Time frame
Absolute increase in hemoglobin levels from baseline after 12 weeksTimepoint: 12 weeks	—

Secondary

Measure	Time frame
Change in iron profile (serum iron, serum transferrin, total iron-binding capacity, ferritin, transferrin saturation) from baseline Timepoint: 12 weeks;Changes in hepcidin and low-density lipoprotein levels from baselineTimepoint: 12 weeks;Percentage increase in hemoglobin levelTimepoint: 12 weeks;Proportion of children achieving specific target hemoglobin levels (11-12 g/dL)Timepoint: 12 weeks;Proportion of children with treatment emergent adverse events/severe adverse eventsTimepoint: 12 weeks	—

Measure

Time frame

Change in iron profile (serum iron, serum transferrin, total iron-binding capacity, ferritin, transferrin saturation) from baseline Timepoint: 12 weeks;Changes in hepcidin and low-density lipoprotein levels from baselineTimepoint: 12 weeks;Percentage increase in hemoglobin levelTimepoint: 12 weeks;Proportion of children achieving specific target hemoglobin levels (11-12 g/dL)Timepoint: 12 weeks;Proportion of children with treatment emergent adverse events/severe adverse eventsTimepoint: 12 weeks

—

Countries

India

Contacts

Public ContactSunil Kushwah

PGIMER, Chandigarh

ktiewsoh@rediffmail.com

Outcome results

None listed

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