EUCTR2014-004555-31-RO进行中（未招募）不适用
A Phase 3 Multicenter, Multi-dose, Open-label Maintenance Study to Investigate the Long-term Safety and Efficacy of ZS (Sodium Zirconium Cyclosilicate), an Oral Sorbent, in Subjects with Hyperkalemia, including a Randomized, Double-blind, Placebo controlled, Withdrawal Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 750
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.Provision of written informed consent.
- •2.Age 18 years and older.
- •3.For all subjects enrolled outside Germany: Two consecutive i STAT potassium values, measured 60 (+/-15) minutes apart, both = 5.1 mmol/L and measured within 1 day before the first dose of ZS on Acute Phase Study Day 1.
- •For all subjects enrolled in Germany: Two consecutive i-STAT potassium values, measured 60 (± 15) minutes apart, both = 5.1 mmol/L and = 6.5 mmol/L and measured within 1 day before the first dose of ZS on Acute Phase Study Day 1.
- •4.Ability to have repeated blood draws or effective venous catheterization.
- •5.5. For all subjects outside the European Union: Women of childbearing potential must have a negative pregnancy test within 1 day prior to the first dose of ZS on Acute Phase Study Day 1 and sexually active women of childbearing potential must be using 2 forms of medically acceptable contraception with at least one being a barrier method. Women who are surgically sterile or those who are postmenopausal for at least 2 years are not considered to be of childbearing potential.
- •For all subjects in the European Union: Women of childbearing potential must have a negative pregnancy test within 1 day prior to the first dose of ZS on Acute Phase Study Day 1 and sexually active women of childbearing potential must be using a highly effective medically acceptable contraception such as:
- •combined or hormonal contraception associated with inhibition of ovulation
- •progesterone only hormonal contraception, associated with inhibition of ovulation
- •IUD (intrauterine device)
- •IUS (intrauterine hormone-releasing system)
- •bilateral tubal occlusion
- •vasectomised partner
- •sexual abstinence (True abstinence in line with the subjects preferred and usual lifestyle. Subjects practicing abstinence will agree to have a documented second acceptable method of birth control should they become sexually active during the course of study participation)
- •Women who are surgically sterile or those who are postmenopausal for at least 2 years are not considered to be of childbearing potential.
- •Note: Controlled diabetic subjects are eligible for enrollment. Whenever possible, all blood draws collected before meals should be collected prior to insulin/insulin analog treatment.
- •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 385
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 365
排除标准
- •1.Pseudohyperkalemia signs and symptoms, such as hemolyzed blood specimen due to excessive fist clenching to make veins prominent, difficult or traumatic venipuncture, or history of severe leukocytosis or thrombocytosis.
- •2.Subjects treated with lactulose, Rifaximin, or other non-absorbed antibiotics for hyperammonemia within 7 days prior to first dose of ZS on Acute Phase Study Day 1.
- •3.Subjects treated with sodium polystyrene sulfonate (SPS; eg, Kayexalate®) or calcium polystyrene sulfonate (eg, Resonium) within 3 days prior to first dose of ZS on Acute Phase Study Day 1.
- •4.Subjects with a life expectancy of less than 12 months.
- •5.Subjects who are severely physically or mentally incapacitated and who, in the opinion of investigator, are unable to perform the subjects’ tasks associated with the protocol.
- •6.Women who are pregnant, lactating, or planning to become pregnant.
- •7.Subjects with diabetic ketoacidosis.
- •8.Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated.
- •9.Known hypersensitivity or previous anaphylaxis to ZS or to components thereof.
- •10.Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry.
- •11.Subjects with cardiac arrhythmias that require immediate treatment.
- •12.Subjects on dialysis.
- •13.Subjects randomized into the previous ZS-002, ZS-003, ZS-004, or ZS-004E studies.
- •14. Documented GFR < 15 mL/min within 90 days prior to study entry.
- •15. For Germany only: Subjects presenting with QTc Interval of 450 ms AND additional risk factors for Torsade de pointes (e.g. heart failure or family history of long QT-syndrome) AND taking concomitant medications causing QT prolongation.
- •16. For Germany only: Patients who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- •17. For Germany only: Subjects who are dependents of either the Sponsor, Investigator or Institution.
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