A Randomized, Double-Blinded, Placebo-Controlled, Crossover, Multicenter Phase III Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in Chronic Kidney Disease Patients Receiving Chronic Hemodialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 718
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-emergent Adverse Events
研究概览
简要总结
The purpose of the parent study is to assess the short-term safety and tolerability of soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of representative adult chronic kidney disease patients on hemodialysis (CKD-HD).
The purpose of the extension study is to assess the long-term safety and tolerability of SFP.
详细描述
Parent Study: randomized, double-blinded, crossover, up to 6 weeks, 700 patients. Patients were randomized to receive SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate or placebo (standard liquid bicarbonate concentrate) x 2 weeks, then a 1 week washout, then crossed over to the alternate treatment x 2 weeks.
Extension Study: open-label, single active arm, uncontrolled study, up to 53 weeks, 300 patients. Following completion of the RMTI-SFP-6 parent study, patients could enter the extension study, where they received SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate for up to 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Adult ≥ 18 years of age.
- •Has chronic kidney disease (CKD) receiving maintenance hemodialysis (HD) (CKD-HD subjects) and regularly undergoing 2 or more dialysis sessions per week.
- •Stable pre-dialysis Hgb ≥ 9.0 to ≤ 12.5 g/dL.
- •Stable pre-dialysis TSAT ≥ 15% to ≤ 45%.
- •Stable pre-dialysis ferritin ≥ 100 to ≤ 1200 µg/L (1200 ng/mL).
排除标准
- •Any previous exposure to SFP.
- •Therapy with intravenous, intramuscular or oral iron at any time between the first/screening visit and the randomization visit, or anticipated requirement for iron supplementation during the study period.
- •Non-tunneled vascular catheter for dialysis.
- •Scheduled for kidney transplant within the next 8 weeks.
- •Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to screening, or during screening period prior to randomization.
- •Hospitalization within 1 month prior to screening (except for vascular access surgery).
- •Extension Study, Open Label, Single Active Arm:
- •Key Inclusion Criteria:
- •Participated in Parent Study RMTI-SFP-6 and completed the follow-up/early term visit.
- •Hemoglobin ≤12.0 g/dL at screening.
- •TSAT ≤45% at screening. (Excursion of TSAT by ≤10% outside this range permitted only if all other inclusion/exclusion criteria are met).
- •Serum ferritin ≤1000 µg/L at screening. (Excursion of ferritin by ≤10% outside this range permitted only if all other inclusion/exclusion criteria are met).
- •Key Exclusion Criteria:
- •Had a serious adverse event attributable (i.e., probably, possibly, or definitely related) to study drug or had an adverse event attributable to study drug that necessitated premature withdrawal from the double-blind, placebo-controlled crossover phase of the parent study RMTI-SFP-
- •Non-tunneled vascular catheter for dialysis.
- •Scheduled for kidney transplant within 12 weeks after entry into extension phase.
- •Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to dosing.
- •Pregnancy or intention to become pregnant during the study.
研究组 & 干预措施
SFP/Placebo
Soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
干预措施: SFP (Drug)
SFP/Placebo
Soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
干预措施: Placebo (Other)
Placebo/SFP
Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
干预措施: SFP (Drug)
Placebo/SFP
Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Treatment-emergent Adverse Events
时间窗: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention.
Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension
时间窗: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met the protocol criteria for intradialytic hypotension. Intradialytic hypotension events were only to have been reported as adverse events if they exceeded the individual subject's baseline pattern of intradialytic hypotension.
Incidence of Related Suspected Hypersensitivity Reactions
时间窗: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met protocol criteria for suspected hypersensitivity reactions.
次要结局
- Incidence of Hemodialysis Vascular Access Thrombotic Events(Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study)
- Incidence of Composite Cardiovascular Events(Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study)
- Incidence of Other Thrombotic Events(Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study)
- Incidence of Systemic/Serious Infections(Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study)
- Incidence of Serious Adverse Events(Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study)