Comparing the effectiveness and safety of oral liposomal iron and conventional iron in treating anemia in children with chronic kidney disease (stages 3–5)
Phase 3
- Conditions
- Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)
- Registration Number
- CTRI/2024/02/062336
- Lead Sponsor
- PGIMER, Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute increase in hemoglobin levels from baseline after 12 weeksTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Change in iron profile (serum iron, serum transferrin, total <br/ ><br>iron-binding capacity, ferritin, transferrin saturation) from baseline <br/ ><br>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