Study of KRX-0502 (Ferric Citrate) Dose Regimens in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and Iron-Deficiency Anemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 24
- 主要终点
- Change From Baseline in Hemoglobin (Hgb) at Week 24
研究概览
简要总结
The objectives of this study are to assess the long-term efficacy and safety of different dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects with non-dialysis dependent chronic kidney disease (CKD).
详细描述
This is a Phase 4, 48-week, randomized, open-label, multicenter clinical study comprised of 2 periods: a 24-week Dose Titration Period, followed by a 24-week Dose Maintenance Period. The study will consist of 12 scheduled clinic visits over a period of 48 weeks and additional visits as needed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated glomerular filtration rate ≥20 mL/min and <60 mL/min
- •Hgb ≥8.5 g/dL and ≤11.5 g/dL
- •Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%
- •Serum intact parathyroid hormone ≤600 pg/mL
排除标准
- •Serum phosphate <3.0 mg/dL
- •Intravenous (IV) iron administered within 4 weeks prior to Screening
- •Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening
- •Blood transfusion within 4 weeks prior to Screening
研究组 & 干预措施
Group 1
KRX-0502 1 tablet thrice daily (TID) with meals
干预措施: KRX-0502 (Drug)
Group 2
KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals
干预措施: KRX-0502 (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin (Hgb) at Week 24
时间窗: Baseline; Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from a mixed model of repeated measures (MMRM), including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
次要结局
- Change From Baseline in Hgb at Week 48(Baseline; Week 48)
- Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 24: Activity Impairment(Baseline; Week 24)
- Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Activity Impairment(Baseline; Week 48)
- Change From Baseline Scores for the Work Productivity and Activity Impairment (WPAI) Questionnaire Adapted for Anemia Associated With Chronic Kidney Disease (CKD) at Week 24: Work-associated Measures(Baseline; Week 24)
- Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Work-associated Measures(Baseline; Week 48)
- Number of Hospitalizations for Participants Who Entered the Dose Maintenance Period(up to Week 48)
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE) for Participants Who Entered the Dose Maintenance Period(up to Week 48)
- Change From Baseline in Ferritin at Week 24(Baseline; Week 24)
- Change From Baseline in Ferritin at Week 48(Baseline; Week 48)
- Change From Baseline in Serum Phosphate at Week 48(Baseline; Week 48)
- Change From Baseline in TSAT at Week 48(Baseline; Week 48)
- Change From Baseline in Serum Phosphate at Week 24(Baseline; up to Week 24)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24(Baseline; Week 24)
- Change From Baseline in Bicarbonate at Week 24(Baseline; Week 24)
- Change From Baseline in Bicarbonate at Week 48(Baseline; Week 48)
- Change From Baseline in C-terminal Fibroblast Growth Factor 23 (FGF23) at Week 24(Baseline; Week 24)
- Change From Baseline in eGFR at Week 48(Baseline; Week 48)
- Change From Baseline in Intact Parathyroid Hormone (iPTH) at Week 24(Baseline; Week 24)
- Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue Scale Score at Week 48(Baseline; Week 48)
- Change From Baseline in iPTH at Week 48(Baseline; Week 48)
- Change From Baseline in C-terminal FGF23 at Week 48(Baseline; Week 48)
- Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 48(Baseline; Week 48)
- Duration of Hospitalizations for Participants Who Entered the Dose Maintenance Period(up to Week 48)
- Time From Randomization to the First Increase From Baseline Hgb of at Least 0.5 Grams Per Deciliter (g/dL) During the Dose Titration Period(from Randomization to Week 24)
- Change From Baseline in Transferrin Saturation (TSAT) at Week 24(Baseline; Week 24)
- Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 24(Baseline; Week 24)
- Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Score at Week 24(Baseline; Week 24)