A Three-Period, 58-Week Safety and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 441
- 试验地点
- 56
- 主要终点
- Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56)
研究概览
简要总结
This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.
详细描述
This trial is a three-period, multicenter, safety and efficacy clinical trial. The first period is a two-week Washout Period, the second period is a 52-week randomized, open-label, active control Safety Assessment Period, and the third period is a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period in only the patients who were randomized to treatment with ferric citrate during the Safety Assessment Period. The primary objectives of this trial are to determine the long-term safety over 52 weeks of up to twelve (12) caplets/day of KRX-0502 (ferric citrate) in patients with ESRD undergoing either hemodialysis or peritoneal dialysis and to determine the efficacy of KRX-0502 (ferric citrate) in the four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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
- •Males or non-pregnant, non-breast-feeding females
- •Age ≥18 years
- •On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening
- •Serum phosphorus ≥6.0 mg/dL for study entry
- •Taking less than 3-18 pills/day of current phosphate binder
- •Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate
- •Willing and able to give informed consent
- •Life expectancy >1 year
排除标准
- •Parathyroidectomy within six months prior to Screening
- •Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
- •History of multiple drug allergies or intolerances
- •History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)
- •Previous intolerance to oral ferric citrate
- •Intolerance to oral iron-containing products
- •Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
- •Inability to tolerate oral drug intake
- •Intolerance to calcium acetate and sevelamer carbonate
- •Any other medical condition that renders the patient unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the patient
- •Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)
- •Inability to cooperate with study personnel or history of noncompliance
- •Unsuitable for this trial per Investigator's clinical judgment.
研究组 & 干预措施
Active Control
PhosLo (calcium acetate) Renvela (sevelamer carbonate)
干预措施: ferric citrate, ca acetate, sevelamer carbonate, placebo (Drug)
Placebo
Placebo
干预措施: ferric citrate, ca acetate, sevelamer carbonate, placebo (Drug)
KRX-0502 (Ferric Citrate)
ferric citrate
干预措施: ferric citrate, ca acetate, sevelamer carbonate, placebo (Drug)
结局指标
主要结局
Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56)
时间窗: 4 weeks
Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.
次要结局
- Change in Mean Serum Ferritin From Baseline to Week 52(52 weeks)
- Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52)(52 weeks)
- IV Iron Analysis(52 weeks)
- ESA Analysis(52 weeks)