A 24-Week, Open-Label, Randomized, 2-Arm Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 36
- 主要终点
- Number of Participants with Serious and Non-serious Treatment-emergent Adverse Events
研究概览
简要总结
This study will be conducted to evaluate the safety and tolerability of ferric citrate in pediatric participants with iron deficiency anemia (IDA) associated with non-dialysis dependent chronic kidney disease (NDD-CKD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 years to <18 years at Screening
- •Body Weight ≥12 kilograms (kg) at Screening
- •Chronic kidney disease (CKD) stage 3 to 5, not on dialysis, with estimated glomerular filtration rate (eGFR) <60 milliliters per minute (mL/min)/1.73 meters squared (m^2) utilizing the "Bedside Schwartz" equation
- •Hemoglobin (Hgb) ≥8.5 and ≤11.5 grams per deciliter (g/dL) at Screening
- •Transferrin saturation (TSAT) ≤25% at Screening
- •Ferritin ≤200 nanograms per milliliter (ng/mL) at Screening
排除标准
- •Serum phosphorus level at Screening:
- •6 to <13 years: ≤4.0 milligrams per deciliter (mg/dL);
- •13 to <18 years: ≤2.7 mg/dL
- •Liver transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) ˃3× the upper limit of normal at Screening
- •Active significant gastrointestinal (GI) disorder, including overt gastrointestinal (GI) bleeding or active inflammatory bowel disease
- •Unable to swallow pills
- •Anemia due to causes other than iron deficiency anemia (IDA) of CKD
- •Intravenous iron therapy or blood transfusion within 4 weeks before the Screening visit
- •Participants with a functioning organ transplant
- •Receipt of any investigational drug within 4 weeks before Screening
- •Phosphate binder use during the Screening period
研究组 & 干预措施
Ferric citrate
Participants aged 12 to <18 years and 6 to <12 years will receive ferric citrate for 24 weeks at a starting dose based on body weight categories.
干预措施: ferric citrate (Drug)
Standard of care
Participants aged 12 to <18 years and 6 to <12 years will receive standard of care treatment for 24 weeks.
干预措施: standard of care (Drug)
结局指标
主要结局
Number of Participants with Serious and Non-serious Treatment-emergent Adverse Events
时间窗: up to Week 28
Number of Participants with Clinically Significant Laboratory Abnormalities or Changes in Laboratory Results
时间窗: up to Week 24
Number of Participants with Treatment-emergent Adverse Events Leading to the Discontinuation of Ferric Citrate
时间窗: up to Week 28
次要结局
- Change from Baseline in Transferrin Saturation (TSAT) to Week 24/Early Termination Visit(Baseline; Week 24)
- Change from Baseline in Serum Phosphorus to Week 24/Early Termination Visit(Baseline; Week 24)
- Change from Baseline in Ferritin to Week 24/Early Termination Visit(Baseline; Week 24)
- Change from Baseline in Hemoglobin to Week 24/Early Termination Visit(Baseline; Week 24)
- Change from Baseline in Calcium to Week 24/Early Termination Visit(Baseline; Week 24)
- Change from Baseline in Bicarbonate to Week 24/Early Termination Visit(Baseline; Week 24)