Physiological Iron Maintenance in End Stage Renal Disease (ESRD) Subjects by Delivery of Soluble Ferric Pyrophosphate (SFP) Via Hemodialysate: The PRIME Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The Percent Change From Baseline in ESA Dose Required to Maintain Hemoglobin in the Target Range, Adjusted for Hgb.
研究概览
简要总结
The purpose of this study is to compare the clinical safety and efficacy of SFP in sparing the need for erythropoiesis stimulating agents (ESAs) required to maintain hemoglobin (hgb) levels in chronic hemodialysis subjects who receive SFP via the dialysate versus subjects who receive conventional dialysate without iron.
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
- 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
- •Male and female subjects ≥ 18 years of age.
- •End-stage renal disease undergoing maintenance hemodialysis 3 to 4 times a week for at least 4 months and expected to remain on this schedule and be able to complete the study. Subjects on a cadaveric transplant list need not be excluded for this reason unless there is an identified donor.
- •Mean Hgb in the range of ≥ 9.5 to ≤ 12.0 g/dL during screening.
- •The difference between the maximum and minimum Hgb values during screening does not exceed 1.0 g/dL.
- •Mean ferritin ≥ 200 to ≤ 1000 µg/L during screening.
- •Mean TSAT ≥ 15% to ≤ 40% during screening.
- •Any and all serum albumin measured during the 2 months preceding randomization must be ≥ 3.0 g/dL.
- •Prescribed ESA dosing remaining in the range of ≥ 4,000 to ≤ 45,000 U/week epoetin or ≥ 12.5 to ≤ 200 µg/week darbepoetin during the 6 weeks preceding randomization.
- •Required IV iron at any time in the 6 months preceding randomization.
排除标准
- •Vascular access for dialysis is a catheter.
- •During the 6 months prior to randomization, infection of the vascular access to be used at the time of randomization.
- •Received a total of > 600 mg IV iron during the 6 weeks prior to randomization.
- •Received any amount of IV or oral iron during the 2 weeks prior to randomization.
- •Change in prescribed ESA dose:
- •Any change in prescribed ESA dose within 4 weeks prior to randomization.
- •The prescribed ESA dose at the time of randomization is > 25% higher or lower than the prescribed dose at 6 weeks prior to randomization.
- •Change in prescribed type of ESA (e.g., epoetin vs. darbepoetin) or route of administration within 6 weeks prior to randomization.
- •Actual ESA dosing missed or withheld for a cumulative total of ≥ 1 week for any reason during the 6 weeks prior to randomization.
- •Known cause of anemia other than anemia attributable to renal disease (e.g., sickle cell disease, thalassemia, pure red cell aplasia, hemolytic anemia, myelodysplastic syndrome, etc.)
- •Scheduled kidney transplant or a donor has been identified but the transplant has not been scheduled.
- •Known ongoing inflammatory disorder (other than Chronic Kidney Disease), such as systemic lupus erythematosus, rheumatoid arthritis, other collagen-vascular diseases, etc.
- •Known active tuberculosis, fungal, viral, or parasitic infection requiring anti-microbial therapy or anticipated to require anti-microbial therapy during the patient's participation in this study. Subjects with hepatitis C, in the absence of cirrhosis, are not excluded from participation in the study if Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels are below 2 times the upper limit of normal on a consistent basis during the 2 months preceding randomization.
- •Occult tuberculosis requiring prophylactic treatment with anti-tubercular drug(s) that overlaps with the patient's participation in this study.
- •Cirrhosis of the liver based on histological criteria or clinical criteria (e.g., presence of ascites, esophageal varices, spider nevi, or history of hepatic encephalopathy).
研究组 & 干预措施
SFP in liquid bicarbonate
干预措施: Soluble Ferric Pyrophosphate in liquid bicarbonate (Drug)
SFP in liquid bicarbonate
干预措施: Erythrocyte Stimulating Agent (ESA) (Drug)
SFP in liquid bicarbonate
干预措施: Intravenous (IV) Iron (Drug)
Placebo: Conventional Liquid Bicarbonate
Control concentrate lacking SFP does not contain SFP (total iron = 0)
干预措施: Erythrocyte Stimulating Agent (ESA) (Drug)
Placebo: Conventional Liquid Bicarbonate
Control concentrate lacking SFP does not contain SFP (total iron = 0)
干预措施: Intravenous (IV) Iron (Drug)
结局指标
主要结局
The Percent Change From Baseline in ESA Dose Required to Maintain Hemoglobin in the Target Range, Adjusted for Hgb.
时间窗: Hemoglobin measured weekly and serum ferritin and Transferrin Saturation (TSAT) determined every other week; ESA dose recorded at each visit for 36 weeks.
The statistical endpoint is the change from baseline between groups at End of Treatment, where the baseline prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the two-week period of time immediately prior to randomization. The end-of-treatment prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the last two weeks of the treatment period.
次要结局
- The Amount of Supplemental Intravenous (IV) Iron Needed During Study Participation.(36 weeks)
- The Distribution of Changes From Baseline in the Prescribed ESA Dose Between the Two Treatment Arms(ESA dose is monitored and recorded at each dialysis session for 36 weeks.)
- Stability of Hemoglobin Over Time (Maintenance of Hemoglobin Between 9.5-11.5 g/dL.(36 weeks)
- Comparison of Iron Delivery to the Erythron From Baseline to End of Treatment Between the Treatment Groups.(36 weeks)