EUCTR2018-001331-48-GB进行中（未招募）1 期
A Phase 3, Dose-Escalating Study in Children With Hyperkalaemia Between Birth and <18 Years of Age to Evaluate Increasing Doses of Sodium Zirconium Cyclosilicate (SZC) Given Three Times Daily for the Correction of Hyperkalaemia and the Effectiveness of the Same Dose of SZC Given Once Daily to Maintain Normokalaemia Among Those Requiring Continuous Treatment.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
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 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 peritoneal dialysis) requiring long term treatment of hyperkalaemia (chronic hyperkalaemia) in the age cohort =2 years, and participants requiring either short- or longterm treatment for hyperkalaemia (acute and chronic hyperkalaemia) in the age cohort <2 years..
- •4. Participants must meet 1 of the following criteria for hyperkalaemia:
- •(a)For participants =2 years of age, mean i STAT K+ level >5.0 mmol/L
- •at Screening. Two consecutive i STAT K+ values, measured 60 (±15)
- •minutes apart, both >5.0 mmol/L and measured within 1 day before the first dose of SZC on CP Study Day 1.
- •(b)For participants <2 years of age, i STAT K+ level >6.0 mmol/L at
- •Screening, measured within 1 day before the first dose of SZC on CP
- •Study Day 1.
- •Note that if Day 1 is the same as the Screening day, the 60 (±15) minute K+ value is the same as the Day 1 time 0 K+ value. However, if Day 1 is not the same day as Screening, then the participant will actually have 3 i STAT-K+ values measured before starting treatment in the CP and the third value which is taken on Day 1 time 0 must also be hyperkalaemic.
- •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 after birth: <450 ms
- •(b)For participants aged >3 days to <12 years: <440 ms
- •(c)For participants =12 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 catheterization.
- •7. Females of childbearing potential must have a negative pregnancy test within 1 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 1 being a barrier method
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 140
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 ischemia (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, betaadrenergic antagonists) and that would be more appropriately treated with other interventions (eg, fluid resuscitation, dose adjustments of medications)
- •6. Participants treated with lactulose, rifaximin (XIFAXAN™), or other
- •nonabsorbed antibiotics for hyperammonaemia within the last 7 days.
- •7. Participants treated with CPS, sodium polystyrene sulfonate (eg,
- •KAYEXALATE™), or patiromer within the last 4 days.
- •8. Participants with a life expectancy of less than 3 months.
- •9. Participants who are known to have tested Human Immunodeficiency Virus (HIV) positive.
- •10. 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.
- •11. Known hypersensitivity or previous anaphylaxis to SZC or to components thereof.
- •12. Participants with cardiac arrhythmias that require immediate treatment.
- •13. Participants with a family history of long QT syndrome.
- •14. Participants on haemodialysis.
- •15. Participants with a history of bowel obstruction.
- •16. Participants with severe gastrointestinal disorder or major
- •gastrointestinal surgery (eg, large bowel resection).
- •17. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- •18. Previous treatment with SZC.
- •19. Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry.
- •20. Previous enrolment in the present study.
- •21. Females who are pregnant, breastfeeding, or planning to become pregnant.
- •22. Judgment 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.
- •23. For the LTMP only: participants who are normokalaemic at Visit 8b and are receiving placebo at Visit 8a of the MP unless they received rescue treatment.
- •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
相似试验
进行中（未招募）
1 期
Follow-Up study in Previously Treated Children to investigate a new FVIII concentrateEUCTR2011-001785-17-PLOctapharma AG50
进行中（未招募）
1 期
Follow-Up study in Previously Treated Children to investigate a new FVIII concentrateSevere Haemophilia AMedDRA version: 14.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-001785-17-CZOctapharma AG60
进行中（未招募）
1 期
Follow-Up study in Previously Treated Children to investigate a new FVIII concentrateSevere Haemophilia AMedDRA version: 14.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-001785-17-FROctapharma AG60
进行中（未招募）
1 期
Follow-Up study in Previously Treated Children to investigate a new FVIII concentrateSevere Haemophilia AMedDRA version: 17.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850EUCTR2011-001785-17-GBOctapharma AG49
进行中（未招募）
不适用
Follow-Up study in Previously Treated Children to investigate a new FVIII concentrateEUCTR2011-001785-17-ROOctapharma AG50