NL-OMON43860已完成3 期
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 - ZS-005
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
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
- 18 至 99（—）
入选标准
- •1). Provision of written informed consent.
- •2).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). 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.
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.
- •15). For Germany only: subjects presenting wiht QTc interval of 450 ms AND addtional 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
- •Note: Subjects who do not meet the criteria for entering the Acute Phase may be re-screened 2 more times during the study.
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