Actively Recruiting
An Open-label Study to Assess Safety and Efficacy of Sodium Zirconium Cyclosilicate in Children With Hyperkalaemia
Led by AstraZeneca · Updated on 2026-05-15
140
Participants Needed
70
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying sodium zirconium cyclosilicate (SZC) to evaluate its safety, effectiveness, and tolerability for treating hyperkalaemia in children under 18 years old. This phase 3, international, open-label study will enroll about 140 children in multiple age groups, starting with those aged 6 to under 12 years and 12 to under 18 years, with plans to include younger children based on safety data. The study aims to see how well SZC can correct and maintain normal potassium levels in children with this condition. Treatment includes three phases: a Correction Phase (CP), a Maintenance Phase (MP), and a Long-Term Maintenance Phase (LTMP). In the CP, participants receive a fixed oral dose of SZC three times daily for up to 3 days until potassium levels normalize. Doses are adjusted by body weight and may increase based on safety monitoring. Those who achieve normal potassium enter the MP, receiving daily SZC for 28 days with dose adjustments as needed. Participants may continue into the LTMP for ongoing treatment and monthly visits if they meet certain criteria. Participants will have regular assessments including blood tests for potassium and other electrolytes, urine tests, ECG monitoring, and evaluation of safety and tolerability throughout all study phases. Researchers will track potassium levels to assess correction and maintenance, as well as measure related hormones and kidney function markers. The total study duration is about 28 weeks, including a 1-week safety follow-up after the last dose. The study is conducted at approximately 46 sites across several countries.
CONDITIONS
Brief Title
An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and assent as appropriate
- Female or male from birth to under 18 years of age
- Participants requiring long-term treatment for hyperkalaemia aged 2 years and older, and short- or long-term treatment for those under 2 years
- Meet specific hyperkalaemia criteria as defined in the protocol
- Age-appropriate normal QT interval on ECG at screening
- Ability to have repeated blood draws or venous catheterization
- Females of childbearing potential must have negative pregnancy test and use two forms of contraception
- For long-term maintenance phase: consent, normokalaemic at end of maintenance phase or hyperkalaemic not on max dose, and judged to benefit from long-term treatment
You will not qualify if you...
- Neonates born before 37 weeks gestation or weighing less than 2500 g
- Neonates with conditions predisposing to intestinal ischemia
- Pseudohyperkalaemia due to fist clenching, hemolysed blood, or blood cell abnormalities
- Hyperkalaemia from crush injury, burns, or secondary causes needing other treatments
- Transient iatrogenic hyperkalaemia
- Recent treatment with certain antibiotics or potassium-binding agents
- Life expectancy less than 3 months
- Known HIV positive status
- Any condition posing undue risk or affecting data quality
- Known allergy or previous anaphylaxis to SZC
- Cardiac arrhythmias needing immediate treatment
- Family history of long QT syndrome
- On haemodialysis
- History of bowel obstruction or major gastrointestinal surgery
- Staff involved in study planning or conduct
- Previous treatment with SZC or investigational drug/device within 30 days
- Previous enrolment in this study
- Pregnant, breastfeeding, or planning pregnancy
- Unlikely to comply with study requirements
- Recent COVID-19 infection within 2 weeks prior to enrolment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 days
Participants receive sodium zirconium cyclosilicate (SZC) three times daily for up to 3 days to achieve normal potassium levels.
Daily visits or assessments during treatment
Duration - 28 days
Participants who achieve normal potassium levels continue SZC treatment once daily for 28 days with possible dose adjustments to maintain normal levels.
Multiple visits during 28 days
Duration - Up to 22 weeks
Participants may continue SZC treatment with monthly visits using the same dose adjustment regimen to maintain normal potassium levels.
Monthly visits
Duration - 1 week
A safety follow-up visit occurs one week after the last dose to monitor participant safety.
1 visit (in-person)
Trial Site Locations
Total: 70 locations
1
Research Site
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Research Site
Atlanta, Georgia, United States, 30322
Withdrawn
3
Research Site
Baltimore, Maryland, United States, 21287
Actively Recruiting
4
Research Site
Grand Rapids, Michigan, United States, 49503
Withdrawn
5
Research Site
St Louis, Missouri, United States, 63104
Withdrawn
6
Research Site
Hackensack, New Jersey, United States, 07601
Completed
7
Research Site
New York, New York, United States, 10029
Withdrawn
8
Research Site
Stony Brook, New York, United States, 11794
Withdrawn
9
Research Site
Charlotte, North Carolina, United States, 28207
Withdrawn
10
Research Site
Winston-Salem, North Carolina, United States, 27157
Withdrawn
11
Research Site
Akron, Ohio, United States, 44308
Completed
12
Research Site
Cincinnati, Ohio, United States, 45229
Actively Recruiting
13
Research Site
Columbia, South Carolina, United States, 29203
Actively Recruiting
14
Research Site
Morgantown, West Virginia, United States, 26506-7900
Withdrawn
15
Research Site
Campinas, Brazil, 13060-904
Actively Recruiting
16
Research Site
São Paulo, Brazil, 01228-200
Actively Recruiting
17
Research Site
São Paulo, Brazil, 04038-002
Actively Recruiting
18
Research Site
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
19
Research Site
Edmonton, Alberta, Canada, T6G 1C9
Withdrawn
20
Research Site
Vancouver, British Columbia, Canada, V6H 3N1
Withdrawn
21
Research Site
Montreal, Quebec, Canada, H3T1C5
Actively Recruiting
22
Research Site
Beijing, China, 100034
Actively Recruiting
23
Research Site
Beijing, China, 100045
Actively Recruiting
24
Research Site
Changsha, China, 410007
Actively Recruiting
25
Research Site
Chengdu, China, 610000
Actively Recruiting
26
Research Site
Chengdu, China, 610041
Actively Recruiting
27
Research Site
Chongqing, China, 400014
Actively Recruiting
28
Research Site
Hangzhou, China, 310052
Actively Recruiting
29
Research Site
Hefei, China, 230001
Withdrawn
30
Research Site
Shanghai, China, 200062
Actively Recruiting
31
Research Site
Shanghai, China, 201102
Actively Recruiting
32
Research Site
Berlin, Germany, D-13353
Withdrawn
33
Research Site
Essen, Germany, 45147
Actively Recruiting
34
Research Site
Heidelberg, Germany, 69120
Actively Recruiting
35
Research Site
Bhubaneswar, India, 751019
Actively Recruiting
36
Research Site
Gurgaon, India, 122001
Not Yet Recruiting
37
Research Site
New Delhi, India, 110060
Withdrawn
38
Research Site
Bunkyō City, Japan, 113-8431
Actively Recruiting
39
Research Site
Fuchu-shi, Japan, 183-8561
Withdrawn
40
Research Site
Fukuoka, Japan, 813-0017
Withdrawn
41
Research Site
Kawasaki-shi, Japan, 211-0063
Withdrawn
42
Research Site
Kobe, Japan, 650-0047
Withdrawn
43
Research Site
Matsumoto-shi, Japan, 390-8621
Withdrawn
44
Research Site
Nakagami-gun, Japan, 903-0215
Actively Recruiting
45
Research Site
Saitama-Shi, Japan, 330-8777
Withdrawn
46
Research Site
Sendai, Japan, 989-3126
Withdrawn
47
Research Site
Shinjuku-ku, Japan, 162-8666
Actively Recruiting
48
Research Site
Shizuoka, Japan, 420-8660
Actively Recruiting
49
Research Site
Bialystok, Poland, 15-274
Completed
50
Research Site
Krakow, Poland, 30-663
Withdrawn
51
Research Site
Lodz, Poland, 93-338
Completed
52
Research Site
Warsaw, Poland, 02-097
Actively Recruiting
53
Research Site
Bucharest, Romania, 022322
Actively Recruiting
54
Research Site
Bucharest, Romania, 077120
Withdrawn
55
Research Site
Cluj-Napoca, Romania, 400370
Actively Recruiting
56
Research Site
Târgu Mureş, Romania, 540136
Withdrawn
57
Research Site
Timișoara, Romania, 300011
Actively Recruiting
58
Research Site
Samara, Russia, 443095
Withdrawn
59
Research Site
Esplugues de Llobregat, Spain, 08950
Actively Recruiting
60
Research Site
Madrid, Spain, 28041
Actively Recruiting
61
Research Site
Dnipropetrovsk, Ukraine, 49100
Suspended
62
Research Site
Kharkiv Region, Ukraine, 61075
Suspended
63
Research Site
Kyiv, Ukraine, 04050
Suspended
64
Research Site
Odesa, Ukraine, 65038
Withdrawn
65
Research Site
Sumy, Ukraine, 40031
Suspended
66
Research Site
Zaporizhzhia, Ukraine, 69063
Completed
67
Research Site
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
68
Research Site
Hampshire, United Kingdom, SO16 6YD
Actively Recruiting
69
Research Site
Manchester, United Kingdom, M13 9WL
Completed
70
Research Site
Nottingham, United Kingdom, NG7 2UH
Terminated
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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