NCT03984760已完成3 期
A Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Study to Assess the Efficacy and Safety of Ferric Citrate Capsules for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 24
- 主要终点
- The change in serum phosphorus levels
研究概览
简要总结
To evaluate the efficacy and safety of ferric citrate capsules for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis
详细描述
This is a multicenter, randomized, open-label, active-controlled, parallel, phase III study which aims to assess the efficacy and safety of ferric citrate capsules for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis. This study is consisting of a Screening/Washout period (14 days) and a Treatment/Observation period (12 weeks). During the Treatment period, the subjects will be randomly assigned to the ferric citrate capsule group (study group) or sevelamer carbonate tablet group (control group) in the ratio of 1:1.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to give written informed consent.;
- •Between the age of 18 and 75 years (including the boundary value);
- •Patients who maintain the hemodialysis schedule as 3 times a week and the dialysis schedule should remain unchanged during the study period;
- •At Screening, patients who have received phosphate binder for at least 4 weeks and have a serum phosphorus level between 2.5 and 8.0 mg/dL (0.81 to 2.58 mmol/L) (excluding the boundary value) after treatment;
- •Patients with a serum phosphorus level between 5.5 and 10.0 mg/dL (1.78 to 3.23 mmol/L) (excluding the boundary value) after washout.
排除标准
- •Patients with severe gastrointestinal diseases (such as acute peptic ulcer, chronic ulcerative colitis, regional enteritis, ileus) or patients with dysphagia;
- •Patients with a history of gastrectomy or enterectomy (excluding endoscopic excision or caecectomy) or patients who had undergone gastrointestinal surgery within 3 months prior to Screening;
- •Patients with severe constipation (times of bowel movement≤ 1 time/week), chronic diarrhea (times of bowel movement≥ 4 times/day), severe gastrointestinal motility disorder;
- •Patients with hemochromatosis or patients receiving treatment for iron overload, or patients with a serum ferritin level >800 ng/mL or TSAT >50% at Screening;
- •Patients with a serum calcium level (corrected) <8.0 mg/dL (2.0 mmol/L) or >11.0 mg/dL (2.75 mmol/L) after washout;
- •Patients with intact-PTH>800pg/mL at Screening, or patients undergone parathyroid surgery within 6 months prior to Screening or requiring parathyroid surgery;
- •Patients who received blood transfusions for treating anemia within 3 months prior to Screening;
- •Patients who require phosphorus-binding agents containing aluminum, magnesium, calcium and lanthanum in addition to the study drug or patients who require an antacid with a phosphorus binding effect during the study period;
- •Patients who require citrate preparation as an anticoagulant during hemodialysis treatment during the study period;
- •Patients with impaired liver function (hepatic dysfunction or serum total bilirubin, aspartate aminotransferase or alanine aminotransferase ≥ 2 times the upper limit of normal) or patients with cirrhosis;
- •Patients with cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.) or cardiovascular disease (congestive heart failure of Class III or severer in NYHA classification, acute myocardial infarction, unstable angina, etc.) requiring hospitalization within 6 months prior to Screening;
- •Patients who are known to be intolerant to sevelamer carbonate tablet;
- •Patients with a history of allergies to iron preparations or those who are intolerant to iron preparations;
- •Patients who are scheduled to have a kidney transplant during the study period;
- •Patients with a current or past history of malignancy within 5 years prior to Screening;
- •Women who are pregnant or lactating, or patients who are unable to take effective contraception from screening to 6 months after discontinuation (including male subjects and their female spouses);
- •Patients who had participated in other clinical studies and other received investigational drug product within 1 month or 5 half-lives of the drug product (whichever is longer) prior to Screening;
- •Patients who are not suitable for participating in the trial according to the investigator's judgment;
- •Patients who are unwilling or unable to follow the protocol process.
研究组 & 干预措施
Ferric Citrate Capsule
Experimental
Ferric Citrate Capsule, product specification: 500 mg/cap, manufactured by Panion & BF Biotech Inc.
干预措施: Ferric Citrate (Drug)
Sevelamer Carbonate Tablet
Active Comparator
Sevelamer carbonate tablet group, product specification: 800 mg/tablet, manufactured by Genzyme Ireland Limited
干预措施: Sevelamer Carbonate (Drug)
结局指标
主要结局
The change in serum phosphorus levels
时间窗: 12 Weeks
The change in serum phosphorus levels at the end of treatment (Visit 10 or ET) as compared to baseline (before the first dose).
次要结局
- The response rate of serum phosphorus(12 Weeks)
- Serum phosphorus levels(12 Weeks)
- The proportion of subjects whose serum phosphorus levels reached the target range.(12 Weeks)
- The change in serum calcium (corrected) levels(12 Weeks)
- The change in the [Ca] × [P] product relative(12 Weeks)
- The change in the level of intact-PTH levels(12 Weeks)
研究者
研究点 (24)
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