EUCTR2020-003229-47-ES进行中（未招募）1 期
Phase III, multicenter, open-label, randomized clinical trial to evaluate efficacy of Sodium Zirconium Cyclosilicate (Lokelma) compared to standard of care to manage hyperkalemia in patients with chronic kidney disease (CKD) and heart failure history
Instituto de Investigación Sanitaria INCLIVA0 个研究点目标入组 78 人开始时间: 2021年12月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients must present serum potassium levels of 5.5-6.5 mEq/L at the day of inclusion.
- •2. Provision of patient or legal representative informed consent prior to any study specific procedures.
- •3. Previous history of heart failure (cardiorenal syndrome) established as a HF diagnose which has been present for at least 3 months.
- •4. Individuals receiving background standard of care for HF and treated according to locally recognized guidelines. Specific treatment should include RAASi and/or MRA treatment at first consultation and at least should have been stable for = 4 weeks at maximum tolerated doses.
- •5. Patients with CKD not on dialysis (Stages 2-5: estimated glomerular filtration rate (eGFR) between 15-60 ml/min/1,73m2 or eGFR between 60-90 ml/min/ 1.73 m2 with albuminuria/creatinuria (> 30 mg/g) in the previous three months). The estimated GFR can be reported by the laboratory or calculated by the researcher with serum creatinine, age, and sex (CKD-EPI equation).
- •6. At least 18 years at the time of signing ICF.
- •7. Negative pregnancy test (urine or serum) for female subjects of childbearing potential.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 39
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 39
排除标准
- •1. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
- •2. Previous enrollment or randomization in the present study.
- •3. HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease.
- •4. Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrollment.
- •5. Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting or valvular repair/replacement within 12 weeks prior to enrollment or planned to undergo any of these operations after randomization).
- •6. Implantation of a Cardiac Resynchronization Therapy (CRT) device or Implantable Cardioverter Defibrillator (ICD) within 12 weeks prior to enrollment or intent to perform atrial fibrillation ablation or to implant a CRT or ICD device.
- •7. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or transplantation or implantation expected after randomization
- •8. Oropharingeal dysfunction that precludes normal swallow.
- •9. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
- •10. Patients with amputated limbs or pacemaker devices will be excluded of bioimpedance analysis.
- •11. Participation in another clinical study with an investigational product during the last 6 months.
- •12. Patients with a known hypersensitivity to SZC or any of the excipients of the product.
- •13. Treated with potassium binding resins such as sodium polystyrene sulfonate (SPS; e.g. Kayexalate®) or calcium polystyrene sulfonate (CPS; e.g. Resonium®) or the cation exchange polymer, patiromer sorbitex calcium (Veltassa®), within 7 days prior to the first dose of study drug.
- •14. Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
- •15. Subjects with a family history of long QT syndrome, presence of cardiac arrhythmias or conduction defects that require immediate treatment, or a QTc (corrected QT interval) of = 550 msec.
- •16. History of QT prolongation associated with other medications that required discontinuation of that medications.
- •17. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
研究者
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