CTRI/2019/07/020166Not Applicable3 期
A phase 3 multicenter, prospective, randomized, double-blind, placebocontrolledstudy to investigate the safety and efficacy of ZS (sodium zirconium cyclosilicate), in patients with hyperkalemia - HARMONIZE Asia
试验速览
- 阶段
- 3 期
- 状态
- Not Applicable
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
入选标准
- •Optional Pre-screening part of the study
- •For inclusion in the study patients should fulfill the following criteria:
- •1. Provision of informed consent (pre-screening consent) prior to any study specific procedures
- •2. Female and male patients aged >=18 and <= 90 years.
- •Main part of the study
- •Above inclusion criteria 2 is also applied to the Main part of the study. In addition, for
- •inclusion in the study patients should fulfill the following criteria:
- •3. Provision of informed consent prior to any study specific procedures
- •4. Two consecutive i-STAT potassium values, measured 60-minutes (± 10 minutes)
- •apart, both >= 5.1 mmol/L and measured within 1 day of the first ZS dose on 48-
- •hour open-label initial phase Day 1
- •5.Ability to have repeated blood draws or effective venous catheterization
- •6.Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of ZS/matching placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable;additional barrier methods in conjunction with spermicide must be used
- •7. Patient must have at least one of the following risk factors for Hyperkalemia
- •(a) Chronic Kidney Disease
- •(b) Heart Failure
- •(c) Diabetes Mellitus
- •8. Documented evidence of at least 2 episodes of hyperkalemia with serum potassium level of >= 5.1 mmol/l at least one week apart within 6 months prior to informed consent.
排除标准
- •Optional Pre-screening part of the study
- •1.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •2.Participation in another clinical study with an investigational product during the last 3 months
- •3.Presence of any condition which, in the opinion of the investigator, places the patient at undue risk or potentially jeopardizes the quality of the data to be generated
- •Main part of the study
- •Above exclusion criteria are also applied to the Main part of the study. In addition, patients should not enter the study if any of the following exclusion criteria are fulfilled:
- •4.Pseudohyperkalemia signs and symptoms, such as hemolyzed blood specimen due to excessive fist clenching to make veins prominent, difficult or traumatic venepuncture, or history of severe leukocytosis or thrombocytosis
- •5.Patients treated with lactulose, xifaxan (rifaximin) or other non-absorbed antibiotics for hyperammonemia within 7 days prior to the first dose of study drug
- •6.Patients treated with resins (such as sevelamer acetate or sodium polystyrene sulfonate [SPS; e.g. Kayexalate®]), calcium acetate, calcium carbonate, or lanthanum carbonate, within 7 days prior to the first dose of study drug
- •7.Patients with a life expectancy of less than 3 months
- •8.Patients who are severely physically or mentally incapacitated and who in the opinion of investigator are unable to perform the subjectsâ?? tasks associated with the protocol
- •9.Female patients who are pregnant, lactating, or planning to become pregnant
- •10.Patients with diabetic ketoacidosis
- •11.Known hypersensitivity or previous anaphylaxis to ZS or to components thereof
- •12.Patients with cardiac arrhythmias that require immediate treatment
- •13.Patients on dialysis
- •14.Patients who are blood donors should not donate blood during the study and for 3months following their last dose of ZS
- •15.Patients who need hospitalization after taking blood samples on day 1 of the 48- hour open-label initial phase
研究者
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