NCT05766839招募中2 期
A 2-Part, Open-Label, Phase 2, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer in Children Under 12 Years of Age With Hyperkalaemia (EMERALD2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 38
- 主要终点
- Change in potassium levels (mmol/L)
研究概览
简要总结
A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paediatric participants (<12 years of age) with hyperkalaemia at screening.
- •Participant's age should not reach 12 years during the 28 days of the pharmacodynamic/dose-ranging period.
- •Participant is able to receive regular external feeding and medication, including via tubes, i.e., percutaneous endoscopic gastrostomy (PEG) or entero-gastric feeding tube.
- •At screening/baseline, the results from 2 separate and consecutive potassium assessments using the same measurement method (whole blood, plasma, or serum) need to be above the age-appropriate upper limit of normal (ULN).
- •If taking any renin-angiotensin aldosterone system inhibitors (RAASi), beta blockers, fludrocortisone, or diuretic medications, must be on a stable dose for at least 14 days prior to screening.
- •Parent(s) or legally authorised representative(s) or another appropriate person delegated by the legally authorised representatives must be available to help the study-site personnel ensure follow-up; accompany the participant to the study site on each assessment day; accurately and reliably dispense investigational product as directed.
- •Females of childbearing potential must be non-lactating, must have a negative pregnancy test at screening, and must have used an effective, acceptable form of contraception (e.g., abstinence) for at least 1 month before patiromer administration. Females of childbearing potential must agree to continue using contraception throughout the study and for 1 month after the last dose of patiromer.
- •If undergoing peritoneal dialysis, participants must be on a stable treatment plan for a minimum of 4 weeks prior to screening, or at least 8 weeks prior to screening if newly initiated on peritoneal dialysis.
排除标准
- •Preterm birth infants with <37 weeks of gestation cannot be included in Cohort
- •Participants who due to their general condition, e.g., anaemia or low body weight, are not suitable to have blood volume withdrawn.
- •Any of the following renal conditions: maintenance haemodialysis, renal artery stenosis, and acute kidney injury (defined by 2012 Kidney Disease Improving Global Outcomes) or a history of acute renal insufficiency in the past 3 months. Note: Chronic kidney disease (CKD) is not excluded.
- •A history of or current diagnosis of a severe gastrointestinal (GI) diagnosis or surgery that could affect GI transit of the drug (delayed gastric emptying), such as a severe swallowing disorder, severe gastroesophageal reflux, uncorrected pyloric stenosis, intussusception, any other intestinal obstruction (e.g., Hirschsprung disease, chronic intestinal pseudo-obstruction, clinically significant postsurgical abdominal adhesions) or any gut-shortening surgical procedure prior to screening. Pre-gastric above-mentioned pathologies may be disregarded in case of existence of a PEG or entero-gastric feeding tube, as the PEG or entero-gastric feeding tube will serve for nutrition and investigational product administration.
- •Active cancer, currently on cancer treatment, or history of cancer in the past 2 years (except for non-melanoma skin cancer).
- •Scheduled for kidney transplant procedure during the first 28 days after Day
- •History of sudden infant death in a sibling (only for participants <2 years of age at screening).
- •Use of the following medications if doses have not been stable for at least 14 days prior to screening or if doses are anticipated to change during the 4-week pharmacodynamic/
- •Dose-ranging period: digoxin, bronchodilators, theophylline, heparins (including low molecular heparins), tacrolimus, mycophenolate mofetil, cyclosporine, trimethoprim, or cotrimoxazole.
- •Use of any investigational product for an unapproved indication within 30 days prior to screening or within 5 half-lives, whichever is longer.
- •Known hypersensitivity to patiromer or its components.
- •If the child is being breastfed:
- •There is suspicion of current alcohol or substance misuse/abuse in breastfeeding mother.
- •The breastfeeding mother is taking potassium supplements
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Patiromer
Experimental
4-week pharmacodynamic /dose-ranging period
Cohort 1: 6 to less than (<)12 years of age Cohort 2: 2 to <6 years of age Cohort 3: 0 to <2 years of age; In Cohort 3, a minimum of 3 study participants will be assessed in the subgroup of 0 to <6 months and another 3 study participants in the subgroup 6 to <24 months of age.
干预措施: Patiromer (Drug)
结局指标
主要结局
Change in potassium levels (mmol/L)
时间窗: From baseline to Day 28
May be measured as serum, plasma, whole blood, potassium
次要结局
- Change from baseline in body temperature (Celsius)(From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks)
- Number of patients with ECG abnormalities(From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks)
- Change in potassium levels (mmol/L)(From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks)
- Change from baseline in chemistry laboratory evaluation: Calcium (mg/dL)(From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks)
- Occurrence of treatment-emergent adverse events (TEAEs)(Part 1: Day 1 up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to follow-up visit (Up to 54 weeks))
- Change from baseline in resting heart rate (beats per minute)(From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks)
- Change from baseline in systolic blood pressure (mmHg)(From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks)
- Change from baseline in chemistry laboratory evaluation: Magnesium (mg/dL)(From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks)
- Occurrence of serious adverse events (SAEs)(Part 1: Day 1 up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to follow-up visit (Up to 54 weeks))
- Change from baseline in diastolic blood pressure (mmHg)(From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks)
- Change from baseline in chemistry laboratory evaluation: Blood urea nitrogen (mEq/L)(From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks)
- Change from baseline in chemistry laboratory evaluation: Phosphate (mg/dL)(From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks)
- Change from baseline in chemistry laboratory evaluation: Serum bicarbonate (mEq/L)(From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks)
- Occurrence of blood potassium below the lower limit of normal (LLN) (mmol/L)(Part 1: Screening up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to end of treatment (Up to 52 weeks))
- Occurrence of blood potassium above the upper limit of normal (ULN) (mmol/L)(Part 1: Screening up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to end of treatment (Up to 52 weeks))
- Change from baseline in chemistry laboratory evaluation: Potassium (mEq/L)(From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks)
- Change from baseline in chemistry laboratory evaluation: Sodium (mEq/L)(From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks)
- Change from baseline in haematology laboratory evaluation: Red blood cells count (10^12/L)(From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52))
- Change from baseline in haematology laboratory evaluation: Haematocrit (%)(From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52))
- Change from baseline in chemistry laboratory evaluation: Creatinine (mg/dL)(From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks)
- Change from baseline in haematology laboratory evaluation: White blood cells (10^9/L)(From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52))
- Change from baseline in haematology laboratory evaluation: Haemoglobin (10^12/L)(From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52))
- Change from baseline in haematology laboratory evaluation: Platelet count (10^9/L)(From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52))
- Occurrence of blood magnesium at levels specified in protocol (mmol/L)(Part 1: Screening up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to end of treatment (Up to 52 weeks))
- Change from baseline in haematology laboratory evaluation: Blood fluoride (ng/mL)(From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52))
- Occurrence of abnormal clinical laboratory value findings(Part 1: Screening up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to end of treatment (Up to 52 weeks))
研究者
研究点 (38)
Loading locations...
相似试验
终止
1 期
Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA)Juvenile Idiopathic ArthritisNCT06222034Alfasigma S.p.A.9
已完成
3 期
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)Chronic Kidney Disease (CKD)Hyperkalemia (HK)NCT01810939Relypsa, Inc.243
已完成
3 期
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Children With EpilepsyEpilepsies, PartialSeizuresEpilepsyNCT00236743Johnson & Johnson Pharmaceutical Research & Development, L.L.C.90
终止
2 期
An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on HemodialysisHyperkalemiaNCT02033317Relypsa, Inc.6
已完成
3 期
A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I DisorderAffective Disorders, PsychoticMood DisordersMental DisordersBipolar DisorderNCT00035802Johnson & Johnson Pharmaceutical Research & Development, L.L.C.13