Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate) Health Condition 2: N184- Chronic kidney disease, stage 4 (severe) Health Condition 3: N185- Chronic kidney disease, stage 5
Conditions
Interventions
Intervention1: Ferric citrate: Weight based dose of Ferric citrate
3 g/day for children 31 kg
5 g/day for children 31 50 kg
6 g/day for children 51 kg
Drug: Ferric citrate-Phoscut FER Ferric
Sponsors
PGIMER, Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 6 to 14 years 2. Estimated glomerular filtration rate of less tha 60ml per min per 1.73m2 by Modified Schwartz formula 3. Serum phosphate levels greater than 5mg per dL or above the age-adjusted reference range on two occasions 4. Haemoglobin less than 11.5 g per dl for 5-11 years and less than 12 g per dl for 12-14 years. 5. Serum Ferritin less tha 500ng per ml and Transferrin saturation less than 50 percentage 6. Doses of iron, ESA, vitamin D3, calcium carbonate, and calcitriol must be stable for at least 2 weeks before enrolment. 7. Children who can take oral tablets 8. Parents or guardians willing to come for follow-up and comply with the treatment regime
Exclusion criteria
Exclusion criteria: 1. Patients on dialysis 2. Prior solid organ transplantation 3. History of intestinal malabsorption, gastrointestinal bleeding, severe hepatic dysfunction 4. Active infection or malignancy 5. Retroviral disease 6. Haemochromatosis 7. Known allergy to phosphate binders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of oral ferric citrate in reducing serum phosphate levels at 6 months of treatment in children aged 4 14 years with hyperphosphatemia in CKD stages 3-5.Timepoint: To assess the efficacy of oral ferric citrate in reducing serum phosphate levels at 6 months of treatment in children aged 4 14 years with hyperphosphatemia in CKD stages 3-5. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effect of ferric citrate on fibroblast growth factor 23 levels, which is a key regulator of phosphate metabolism and cardiovascular risk.Timepoint: 6 months;2. To assess the influence of ferric citrate on cardiovascular outcomes by determining the changes in the left ventricular mass index (LVMI) as a measure of cardiac remodellingTimepoint: 6 months;3. To assess the changes in iron indices (hemoglobin, ferritin, and transferrin saturation) from baseline to the end of treatmentTimepoint: 6 months;4. To evaluate the changes in bone metabolism markers, including calcium, parathyroid hormone, and alkaline phosphatase, from baseline to the end of treatmentTimepoint: 6 months;5. To assess the overall safety and tolerability profile of ferric citrate in pediatric patients with CKD.Timepoint: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks | — |
Countries
India
Contacts
Public ContactLesa Dawman
PGIMER, Chandigarh
Outcome results
None listed