A Single-center, Randomized, 2-Period, Crossover, Study to Explore The Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Safety: Incidences of adverse events
研究概览
简要总结
This study is a randomized study designed as a 2x2 cross-over in two periods (Period 1 and Period 2) to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of EOS789 in patients with chronic kidney disease (CKD) and hyperphosphatemia receiving hemodialysis. Period 1 is double-blind and Period 2 is open-label. Period 1 and Period 2 are identical with regard to the design, inclusion/exclusion criteria, and assessments. EOS789 and its combination with sevelamer carbonate are tested in Period 1 and Period 2 respectively.
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
- Double (Participant, 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
- •Patients with CKD and hyperphosphatemia must meet the following criteria for study entry:
- •Age ≥18 years
- •On thrice-weekly hemodialysis for at least 3 months prior to screening
- •Not having changed dialysis prescription within 4 weeks prior to screening for dialyzer, calcium concentration in dialysate, or dry weight more than 1 kg
- •Receiving stable doses of treatments affecting serum phosphorus for at least 4 weeks prior to screening and willing to discontinue these treatments
排除标准
- •Patients with CKD and hyperphosphatemia who meet any of the following criteria will be excluded from study entry:
- •Uncontrolled diabetes and/or hypertension in the opinion of the investigators
- •Uncontrolled chronic constipation and/or diarrhea in the opinion of the investigators
- •Hospitalization for cardiac disease in previous 3 months
- •Evidence of acute or chronic hepatitis or known liver cirrhosis
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN)
研究组 & 干预措施
Period 1 Arm 1
EOS789 Dose 1 in treatment sequence 1, Placebo in treatment sequence 2
干预措施: Placebo (Drug)
Period 1 Arm 1
EOS789 Dose 1 in treatment sequence 1, Placebo in treatment sequence 2
干预措施: EOS789 (Drug)
Period 1 Arm 2
Placebo in treatment sequence 1, EOS789 Dose 1 in treatment sequence 2
干预措施: EOS789 (Drug)
Period 1 Arm 2
Placebo in treatment sequence 1, EOS789 Dose 1 in treatment sequence 2
干预措施: Placebo (Drug)
Period 2 Arm 1
EOS789 Dose 2 in treatment sequence 1, EOS789 Dose 2 + Sevelamer carbonate in treatment sequence 2
干预措施: EOS789 (Drug)
Period 2 Arm 1
EOS789 Dose 2 in treatment sequence 1, EOS789 Dose 2 + Sevelamer carbonate in treatment sequence 2
干预措施: Renvela (Drug)
Period 2 Arm 2
EOS789 Dose 2 + Sevelamer carbonate in treatment sequence 1, EOS789 Dose 2 in treatment sequence 2
干预措施: EOS789 (Drug)
Period 2 Arm 2
EOS789 Dose 2 + Sevelamer carbonate in treatment sequence 1, EOS789 Dose 2 in treatment sequence 2
干预措施: Renvela (Drug)
结局指标
主要结局
Safety: Incidences of adverse events
时间窗: Up to Day 42 in each treatment sequence
Incidences of adverse events
Safety: Change from baseline in 12 lead ECGs
时间窗: Up to Day 42 in each treatment sequence
Change from baseline in 12 lead ECGs
Safety: Change from baseline in vital signs
时间窗: Up to Day 42 in each treatment sequence
Change from baseline in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate)
Safety: Change from baseline in clinical laboratory tests
时间窗: Up to Day 42 in each treatment sequence
Change from baseline in clinical laboratory tests (hematology, biochemistry, coagulation)
次要结局
- Pharmacokinetics: Plasma concentration of EOS789(Day 4, 9, 10, 11 in the first treatment sequence in each period)
- Pharmacokinetics: Total exposure (area under the curve [AUC])(Day 10 in the first treatment sequence in each period)
- Pharmacokinetics: Maximum concentration (Cmax)(Day 10 in the first treatment sequence in each period)
- Pharmacokinetics: Time to reach Cmax (Tmax)(Day 10 in the first treatment sequence in each period)
- Pharmacokinetics: Removal ratio of EOS789 by hemodialysis at steady state(Day 9 in the first treatment sequence in each period)
- Pharmacodynamics: Intestinal fractional phosphorus absorption and accumulated fecal excretion of phosphorus(Days 11 to 13 in the first treatment sequence and second treatment sequence in each period)
- Efficacy: Change from baseline of serum phosphorus (P), Calcium (Ca), Ca x P, intact parathyroid hormone (PTH), and fibroblast growth factor (FGF23) at Day 13(Day 13 in the first treatment sequence and second treatment sequence in each period)