A Long-Term Safety Extension 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
- 168
- 试验地点
- 34
- 主要终点
- Safety Parameters
研究概览
简要总结
A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may participate in this trial.
详细描述
This study was an open-label, 48-week safety extension of Study KRX-0502-304 (Study 304), to evaluate the safety of long-term use of KRX-0502 in subjects with ESRD for up to 2 years of cumulative exposure. Subjects who completed the Safety Assessment Period (SAP) and, if eligible, the Efficacy Assessment Period (EAP) of Study 304, independent of their assigned treatment arm in the SAP or EAP of Study 304, were eligible for participation in this long-term safety extension study. No new subjects were permitted to enter this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Males or non-pregnant, non-breast-feeding females who participated in the Safety Assessment Period (SAP), and if eligible, the Efficacy Assessment Period (EAP) of Study KRX-0502-304
- •Willing and able to give informed consent
排除标准
- •Subjects on KRX-0502 (ferric citrate) in KRX-0502-304 who were treatment failures in first period
- •Any subject in Study KRX-0502-304 SAP who early terminated from the trial
- •Any subject who participated in Study KRX-0502-304 but declined EAP
- •Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
- •History of malignancy in the last five years
- •Previous intolerance to KRX-0502 (ferric citrate)
- •Intolerance to oral iron-containing products
- •Absolute requirement for oral iron therapy
- •Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.] allowed)
- •Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
- •Inability to tolerate oral drug intake
- •Any other medical condition that rendered the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
- •Inability to cooperate with study personnel or history of noncompliance
- •Unsuitable for this trial per Principal Investigator's (PI) clinical judgment.
研究组 & 干预措施
Ferric Citrate
Open label extension of those completing study KRX-0304
干预措施: ferric citrate (Drug)
结局指标
主要结局
Safety Parameters
时间窗: 48 Weeks
Safety was assessed by recording and monitoring adverse events (AEs), serious adverse events (SAEs), and sequential laboratory data. Rates of AEs were summarized by system organ class, preferred term, severity, and suspected relationship to KRX-0502 (ferric citrate).
次要结局
未报告次要终点