A Phase 1 interventional study of Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia, sponsored by AstraZeneca. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-19.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 26 studies testing sodium zirconium cyclosilicate in Hyperkalemia — 2 open to participants now, 3 under way, none of them phase 3. sodium zirconium cyclosilicate · Hyperkalemia.
Among the 26 studies testing sodium zirconium cyclosilicate in Hyperkalemia, this one is the 22nd largest by enrollment, is one of 4 that started in 2017, is one of 3 in phase 1, and was the 6th registered.
133 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.
Browse Hyperkalemia studies →2 of the 26 studies testing sodium zirconium cyclosilicate in Hyperkalemia are open now, in 1 country. Recruiting first, the newest first:
Leiden University Medical Center · Sites in Netherlands
Ages 18+
Qianfoshan Hospital
Ages 18–75
By country, each count listing its studies:
sodium zirconium cyclosilicate: first FDA approval 2018 (LOKELMA), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →
Of the 15 Hyperkalemia studies recruiting now, 10 (67%) set no upper age limit and 2 (13%) stop at 75 or younger; 2 take children under 18; none take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 5 · Phase 3 13 · Phase 4 5
First in 2014; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 22 is below the median of 87 across 102 interventional studies indexed under Hyperkalemia.
Median enrollment 116 across the 26 interventional studies. Of the 22 that completed or were terminated, 18 (82%) have results posted.
This tab as a report to print or save as PDF → With an account.
18 of 26 have an industry lead sponsor. The 10 most frequent:
AstraZeneca is the lead sponsor of 3,502 studies on the registry; 273 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
38 studies in Hyperkalemia by AstraZeneca: 1 open now, 2 under way, 1 of them phase 3. Of 36 finished, 22 (61%) have results posted.
Among the 38 studies in Hyperkalemia by AstraZeneca, this one is the 23rd largest by enrollment of the 24 interventional ones that give a count, is one of 6 that started in 2017, is one of 2 in phase 1, and was the 12th registered.
AstraZeneca’s Hyperkalemia studies by the year they started, since 2011.
1 of the studies testing sodium zirconium cyclosilicate in Hyperkalemia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06736184Qianfoshan HospitalThe Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients | 2026-12-31 |
Add it to your calendar (.ics) → With an account.
Among the 26 studies testing sodium zirconium cyclosilicate in Hyperkalemia, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among AstraZeneca’s 38 in Hyperkalemia:
This tab as a report to print or save as PDF → With an account.
This is a single center, inpatient, open label pharmacodynamic study to determine the effect of 5 g and 10 g doses of Sodium Zirconium Cyclosilicate (ZS) administered once daily (qd) for 4 days on potassium and sodium excretion in healthy Chinese subjects on a standardized, low sodium and high potassium diet.
This study will be conducted at 1 study centre in Hong Kong. Approximately 22 Subjects will be screened to achieve 20 subjects completing the study. Subjects will be randomized to receive ZS 5 g or 10 g (1:1) once daily (qd) in conjunction with breakfast and will be continued with a standard diet during the ZS treatment period.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects randomized to this arm will receive ZS 5 g qd in conjunction with breakfast during the ZS treatment period and will be continued with a standard diet.
Drug: Sodium Zirconium Cyclosilicate (ZS)
Subjects randomized to this arm will receive ZS 10 g qd in conjunction with breakfast during the ZS treatment period and will be continued with a standard diet.
Drug: Sodium Zirconium Cyclosilicate (ZS)
Sodium zirconium cyclosilicate (ZS) is a non-absorbed, inorganic crystalline compound that selectively captures potassium ions in exchange for sodium and hydrogen ions in the gastrointestinal tract after oral administration.
Mean change from baseline to ZS treatment period in urine potassium excretion.
The 48- hour urine potassium excretion on Study Days 3 and 4 (baseline) will be compared with 48-hour urine potassium excretion on Study Days 7 and 8 (on study drug).
Time frame: Study Day 3 and 4 vs Study Day 7 and 8.
Mean change from baseline to ZS treatment period in urine sodium excretion.
The 48- hour urine sodium excretion on Study Days 3 and 4 (baseline) will be compared with 48- hour urine sodium excretion on Study Days 7 and 8 (on study drug).
Time frame: Study Day 3 and 4 vs Study Day 7 and 8.
Mean change from baseline to ZS treatment period in serum potassium (S-K).
Mean change in S-K from the Baseline Period (Day 3 and 4) to the ZS Treatment Period (Day 7 and 8).
Time frame: Study Day 3 and 4 vs Study Day 7 and 8.
Number of subjects with adverse events
Time frame: From Day 1 through Follow-up visit
Changes in vital signs
Time frame: Through study completion, up to 10 days
Changes in standard Electrocardiograph (ECG ) parameters
Time frame: Through study completion, up to 10 days
Changes in standard physical examination parameters including height
Time frame: Through study completion, up to 10 days
Changes in standard clinical chemistry lab parameters
Time frame: Through study completion, up to 10 days
Changes in standard hematology lab parameters
Time frame: Through study completion, up to 10 days
Changes in Serum calcium (S-Ca)
Time frame: Through study completion, up to 10 days
Changes in Serum magnesium (S-Mg)
Time frame: Through study completion, up to 10 days
Changes in Serum sodium (S-Na)
Time frame: Through study completion, up to 10 days
Changes in Serum phosphate (S-PO4)
Time frame: Through study completion, up to 10 days
Changes in Serum bicarbonate (S-HCO3)
Time frame: Through study completion, up to 10 days
Changes in Blood urea nitrogen (BUN)
Time frame: Through study completion, up to 10 days
Number of subjects with Serious adverse events
Time frame: Through study completion and follow-up visit, up to 34 Days
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Nov 2017, 0 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sodium zirconium cyclosilicate