Efficacy and safety of Ferric Citrate for Hyperphosphatemia in Children with Chronic Kidney Disease Stages 3 to 5 An open label randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- • 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.
研究概览
简要总结
Hyperphosphatemia is a major complication in children with chronic kidney disease (CKD), contributing to mineral bone disorder, growth impairment, anemia, and cardiovascular disease. Current phosphate binders are limited by side effects and poor tolerability in children. Ferric citrate is a novel oral phosphate binder that also provides bioavailable iron, thereby addressing both hyperphosphatemia and iron deficiency anemia. While extensively studied in adults, data in pediatric CKD patients are scarce.
This single-centre, open-label randomized controlled trial at PGIMER, Chandigarh, will evaluate the efficacy and safety of ferric citrate compared to sevelamer carbonate in children aged 6–14 years with CKD stages 3–5 and hyperphosphatemia. A total of 90 children will be randomized (1:1) to receive either weight-based ferric citrate or standard-dose sevelamer for 24 weeks.
The primary endpoint is the reduction in serum phosphate at 6 months. Secondary endpoints include changes in fibroblast growth factor 23 (FGF23), echocardiographic and carotid intima-media thickness measures of cardiovascular status, iron indices (hemoglobin, ferritin, transferrin saturation), and bone metabolism markers. Safety will be assessed through monitoring adverse events and biochemical markers of iron overload or hypophosphatemia.
The study aims to generate pediatric-specific evidence on ferric citrate as a dual-action therapy, potentially improving phosphate control, iron status, and cardiovascular outcomes in children with CKD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 6 to 14 years
- •Estimated glomerular filtration rate of less tha 60ml per min per 1.73m2 by Modified Schwartz formula
- •Serum phosphate levels greater than 5mg per dL or above the age-adjusted reference range on two occasions
- •Haemoglobin less than 11.5 g per dl for 5-11 years and less than 12 g per dl for 12-14 years.
- •Doses of iron, ESA, vitamin D3, calcium carbonate, and calcitriol must be stable for at least 2 weeks before enrolment.
- •Children who can take oral tablets
- •Parents or guardians willing to come for follow-up and comply with the treatment regime.
排除标准
- •Patients on dialysis
- •Prior solid organ transplantation
- •History of intestinal malabsorption, gastrointestinal bleeding, severe hepatic dysfunction
- •Active infection or malignancy
- •Retroviral disease
- •Haemochromatosis
- •Known allergy to phosphate binders.
结局指标
主要结局
• 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.
时间窗: • 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.
次要结局
- 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.(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 remodelling(6 months)
- 3. To assess the changes in iron indices (hemoglobin, ferritin, and transferrin saturation) from baseline to the end of treatment(6 months)
- 4. To evaluate the changes in bone metabolism markers, including calcium, parathyroid hormone, and alkaline phosphatase, from baseline to the end of treatment(6 months)
- 5. To assess the overall safety and tolerability profile of ferric citrate in pediatric patients with CKD.(4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks)
研究者
Deepthika Sadasivam
PGIMER, Chandigarh