JPRN-jRCT2080223796已完成3 期
A Phase 3b, Multicenter, Prospective, Randomized, Double Blind, Placebocontrolled Study to Reduce Incidence of Pre-dialysis Hyperkalemia With Sodium Zirconium Cyclosilicate
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Provision of informed consent prior to any study specific procedures
- •2. Female or male aged 18 years or more at screening Visit 1. For patients aged < 20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
- •3. Receiving hemodialysis (or hemodiafiltration) 3 times a week for treatment of endstage renal disease (ESRD) for at least 3 months before randomization.
- •4. Patients must have hemodialysis access consisting of an arteriovenous fistula, AV graft, or tunneled (permanent) catheter which is expected to remain in place for the entire duration of the study.
- •5. Pre-dialysis serum K > 5.4 mmol/L after long inter-dialytic interval and >5.0 mmol/L after one short inter-dialytic interval during screening (as assessed by central lab).
- •6. Prescribed dialysate K concentration 3 mmol/L or less during screening
- •7. Sustained Qb 200 ml/min or more and spKt/V 1.2 or more on stable hemodialysis/hemodiafltration prescription during screening with prescription (time, dialyzer, blood flow [Qb], dialysis flow rate [Qd] and bicarbonate concentration expected to remain unchanged during study
- •8. Heparin dose (if used) must be stable during screening and expected to be stable during the study
- •9. Subjects must be receiving dietary counseling appropriate for ESRD patients treated with hemodialysis/hemodiafiltration as per local guidelines, which includes dietary potassium restriction.
排除标准
- •1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca, including ZS Pharma staff and/or staff at the study site)
- •2. Hemoglobin < 9 g/dL on screening (as assessed on Visit 1)
- •3. Lack of compliance with hemodialysis prescription (both number and duration of treatments) during the two-week period preceding screening (100% compliance required)
- •4. Patients treated with sodium polystyrene sulfonate (SPS, Kayexalate, Resonium), calcium polystyrene sulfonate (CPS, Resonium calcium) or patiromer (Veltassa) within 7 days before screening or anticipated in requiring any of these agents during the study
- •5. Myocardial infarction, acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis) within 12 weeks prior to randomization
- •6. Laboratory diagnosis of hypokalemia (K < 3.5 mmol/L), hypocalcemia (Ca < 8.2 mg/dL), hypomagnesemia (Mg < 1.7 mg/dL) or severe acidosis (serum bicarbonate 16 mEq/L or less) in the 4 weeks preceding randomization
- •7. Pseudohyperkalemia secondary to hemolyzed blood specimen (this situation is not considered screening failure, sampling or full screening can be postponed to a later time as applicable).
- •8. Severe leukocytosis (>20 X 109/L) or thrombocytosis (450 X 109/L or more)
- •9. Polycythemia (Hb >14 g/dL)
- •10. Diagnosis of rhabdomyolysis during the 4 weeks preceding randomization
- •11. Patients treated with lactulose, xifaxan (rifaximin) or other non-absorbed antibiotics for hyperammonemia within 7 days prior to the first dose of study drug
- •12. Patients unable to take oral ZS drug mix
- •13. Scheduled date for living donor kidney transplant
- •14. Patients with a life expectancy of less than 6 months
- •15. Female patients who are pregnant or breastfeeding
- •16. Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence.
- •17. Known hypersensitivity or previous anaphylaxis to ZS or to components thereof
- •18. Participation in another clinical study with an investigational product during the last 1 month before screening
- •19. Any medical condition, including active, clinically significant infection, that in the opinion of the investigator or Sponsor may pose a safety risk to a patient in this study, which may confound safety or efficacy assessment and jeopardize the quality of the data, or may interfere with study participation
- •20. Presence of cardiac arrhythmias or conduction defects that require immediate treatment
- •21. History of alcohol or drug abuse within 2 years prior to randomization
- •22. Previous randomization in the present study
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