A 2-Part, Open-Label, Phase 2, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer in Children under 6 Years of Age with Hyperkalaemia (EMERALD 2)

Vifor Pharma, Inc.0 个研究点目标入组 21 人开始时间: 2023年6月13日最近更新: 2024年8月19日

适应症

试验速览

阶段: 2 期
状态: Other
发起方: Vifor Pharma, Inc.
入组人数: 21

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Non-randomized controlled trial
主要目的: Other
盲法: Open (masking not used)

入排标准

年龄范围: 0 至 5（—）
性别: All

入选标准

•1. Paediatric subjects (<6 years of age) with hyperkalaemia at screening.
•2. Subject’s age should not reach 6 years during the 28 days of the PD/ dose-ranging period.
•3. Subject is able to receive regular external feeding and medication, including via tubes, e.g., percutaneous endoscopic gastrostomy (PEG).
•4. At screening/baseline, 2 potassium values need to be above the age-appropriate upper limit of normal (ULN) of the local laboratory. However, the average of the 2 potassium values from 2 separate sample collections (1 sample from screening/baseline and 1 sample not older than 30 days) needs to be above the age-appropriate ULN of the local laboratory plus 0.5 mEq/l (equivalent to 0.5 mmol/l).
•5. In the opinion of the Investigator, the subject is expected to require treatment for hyperkalaemia for at least 28 days upon enrolment in the study.
•6. 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.
•7. Parent(s) or legally acceptable representative(s) has provided the appropriate written informed consent, in accordance with local regulations. The assent of the child should also be obtained when appropriate or if requested by the Institutional Review Board (IRB)/Ethics Committee (EC)/Independent Ethics Committee (IEC). The written informed consent must be provided before any study-specific procedures are performed including screening procedures.
•8. 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 according to the Schedule of Events (Table 1, Table 2) (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); accurately and reliably dispense investigational product as directed.

排除标准

•1. Preterm birth infants with <37 weeks of gestation cannot be included in Cohort B.
•2. Participants who due to their general condition, e.g., anaemia or low body weight are not suitable to have blood volume withdrawn as specified in the Schedule of Events (Table 1, Table 2).
•3. Subjects with pseudo-hyperkalaemia due to haemolysis or to abnormally high numbers of platelets (above ULN), leukocytes (above ULN), or erythrocytes (above ULN) at screening based on results obtained from the local laboratory.
•4. Any subject with evidence of potential potassium-related 12-lead electrocardiogram (ECG) changes (i.e., changes consistent with hyper- or hypokalaemia) at screening.
•5. Any subject with serum magnesium <1.4 mg/dl at screening/baseline.
•6. Any of the following renal conditions: maintenance haemodialysis or peritoneal dialysis, 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: CKD is not excluded.
•7. 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 tube, as the PEG tube will serve for nutrition and investigational product administration.
•8. Liver enzymes (alanine aminotransferase, aspartate aminotransferase) more than 3 times the ULN at screening, based on the local laboratory, as well as subject’s respective age.
•9. Active cancer, currently on cancer treatment, or history of cancer in the past 2 years (except for non-melanoma skin cancer).
•10. Recipient of any organ transplant requiring treatment with immunosuppressive therapy or scheduled for kidney transplant procedure during the first 28 days after Day 1.
•11. History of sudden infant death in a sibling.
•12. Has severe hypoxaemia, respiratory acidosis, asphyxia, or hypotension 3 months before screening based on assessment of the Investigator.
•13. Subjects treated with sodium polystyrene sulphonate, calcium polystyrene sulphonate, or sodium zirconium cyclosilicate within the last 48 hours prior to fulfilling the baseline potassium assessments requested in Inclusion Criterion 4.
•14. 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 PD/dose-ranging period: digoxin, bronchodilators, theophylline, heparins (including low molecular heparins), tacrolimus, mycophenolate mofetil, cyclosporine, trimethoprim, or cotrimoxazole.
•15. Use of any investigational product for an unapproved indication within 30 days prior to screening or within 5 half-lives, whichever is longer.
•16. Known hypersensitivity to patiromer or its components.
•17. In the opinion of the Investigator, parent(s) or legal representative(s) inability to comply with the protocol.
•18. In the opinion of the Investigator, any medical condition, uncontrolled systemic disease, or serious intercurrent illness that would significantly decrease study compliance or jeopar

研究者

发起方

Vifor Pharma, Inc.

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