JPRN-jRCT2031220173招募中3 期
An open-label study to assess safety and efficacy of SZC in paediatric patients with hyperkalaemia - PEDZ-K
Ageishi Yuji0 个研究点目标入组 3 人开始时间: 2022年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
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
- >= 至 < 18age old（—）
- 性别
- All
入选标准
- •1. Provision of written informed consent of the participant or legal representative, and informed assent from the participant (as appropriate)
- •2. Female or male from birth to < 18 years of age.
- •3. Participants (including those receiving a stable peritoneal dialysis regimen) requiring long-term treatment of hyperkalaemia (chronic hyperkalaemia) in the age cohort 2 years or more, and participants requiring either short- or long-term treatment for hyperkalaemia (acute and chronic hyperkalaemia) in the age cohort < 2 years.
- •4. Participants must meet the following criteria for hyperkalaemia:
- •For participants aged 2 years or more, Local Laboratory S-K+ level > 5.0 mmol/L, for participants aged 1 month to < 2 years, Local Laboratory S-K+ level > 6.0 mmol/L and for participants aged 0 to < 1 month, Local Laboratory S-K+ level > 6.5 mmol/L at Screening, measured 3 to 14 days prior to first dose of SZC on CP Study Day 1. This should also be confirmed prior to dosing on Day 1.
- •5. Using digital ECG, QT interval corrected by Bazett's method (QTcB) must meet the age-appropriate parameters at Screening:
- •a. For participants aged 0 to 3 days or less after birth: < 450 ms
- •b. For participants aged >3 days to < 12 years: < 440 ms
- •c. For participants aged 12 or more to < 18 years: < 450 ms (male), < 460 ms (female)
- •All QTcB values outside the reference values specified in the protocol should be manually re-measured and re-calculated, and if there is a difference in measurement between the automatic and manual ECG, the manual measurement should always be considered correct.
- •6. Ability to have repeated blood draws or effective venous catheterisation.
- •7. Females of childbearing potential must have a negative pregnancy test within one day prior to the first dose of SZC on CP Study Day 1 and sexually active females of childbearing potential must be using 2 forms of medically acceptable contraception with at least one being a barrier method
- •8. Optional open-label, LTMP only:
- •a. Provision of written informed consent of the participant or legal representative, and informed assent from the participant (as appropriate) to take part in the LTMP.
- •b. Participants who are normokalaemic at the end of MP or hyperkalaemic and not on maximum dose.
- •c. Participants who would benefit from long-term treatment for their hyperkalaemia, as judged by the Investigator.
排除标准
- •1. Neonates with a gestational age < 37 weeks at birth or a birth weight < 2500 g.
- •2. Term and preterm neonates with suspected conditions predisposing them to intestinal ischaemia (eg, perinatal hypoxia or sepsis).
- •3. Participants with pseudohyperkalaemia caused by excessive fist clenching to enable venepuncture, by haemolysed blood specimens, or by severe leukocytosis or thrombocytosis.
- •4. Participants with hyperkalaemia due to soft-tissue damage from crush injury or burns.
- •5. Participants with hyperkalaemia due to a secondary cause, such as dehydration, excessive use of K+ supplements, or drug use (eg, beta-adrenergic antagonists) and that would be more appropriately treated with other interventions (eg, fluid resuscitation, dose adjustments of medications).
- •6. Participants with transient iatrogenic hyperkalaemia (eg, due to treatment with tacrolimus).
- •7. Participants treated with lactulose, rifaximin (XIFAXAN), or other nonabsorbed antibiotics for hyperammonaemia within the last 7 days.
- •8. Participants treated with CPS, sodium polystyrene sulfonate (eg, KAYEXALATE), or patiromer within the last 4 days prior to first dose of study treatment.
- •9. Participants with a life expectancy of less than 3 months.
- •10. Participants who are known to have tested Human Immunodeficiency Virus (HIV) positive.
- •11. Presence of any condition which, in the opinion of the Investigator, places the participant at undue risk or potentially jeopardises the quality of the data to be generated.
- •12. Known hypersensitivity or previous anaphylaxis to SZC or to components thereof.
- •13. Participants with cardiac arrhythmias that require immediate treatment.
- •14. Participants with a family history of long QT syndrome.
- •15. Participants on haemodialysis.
- •16. Participants with a history of bowel obstruction.
- •17. Participants with severe gastrointestinal disorder or major gastrointestinal surgery (eg, large bowel resection).
- •18. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- •19. Previous treatment with SZC.
- •20. Treatment with a drug or device within the last 30 days prior to first dose of study treatment that has not received regulatory approval at the time of study entry.
- •21. Previous enrolment in the present study.
- •22. Females who are pregnant, breastfeeding, or planning to become pregnant.
- •23. Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- •24. If the participant has evidence of Coronavirus disease 2019 (COVID-19) within 2 weeks prior to enrolment (a positive COVID-19 test or suspicion of COVID-19 infection) the participant cannot be enrolled in the study.
研究者
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