A Phase 2 interventional study of Placebo and Sodium Zirconium Cyclosilicate(ZS) in Hyperkalemia, sponsored by AstraZeneca. Completed at 25 sites in 4 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2020-01-28.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
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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 18th largest by enrollment, is one of 2 that started in 2018, is one of 4 in phase 2, and was the 8th 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 130 Years · all sexes · no healthy volunteers.
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. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 70 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 19th largest by enrollment of the 24 interventional ones that give a count, is one of 2 that started in 2018, is one of 3 in phase 2, and was the 14th 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 |
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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:
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The study is designed to determine if ZS 10g administered up to three times over 10h added to insulin and glucose in patients presenting with hyperkalemia will prove tolerable and efficacious. Patients will receive ZS or Placebo on top of standard of care treatment with insulin and glucose.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
≥ 18 years of age
Potassium ≥5.8 mmol/L
Exclusion Criteria:
Possible pseudohyperkalaemia
Hyperkalaemia caused by any condition for which a therapy directed against the underlying cause of hyperkalaemia would be a better treatment option than treatment with insulin and glucose.
Dialysis session expected within 4h after randomization
Treated with any therapy intended to lower S-K between arriving at the hospital and randomization during Visit 1.
ZS will be administered in addition to insulin and glucose. Insulin and glucose is the current standard of care to treat serum potassium ≥5.8mmol/L.
Drug: Sodium Zirconium Cyclosilicate(ZS) · Drug: Insulin · Drug: Glucose
Placebo will be administered in addition to insulin and glucose. Insulin and glucose is the current standard of care to treat serum potassium ≥5.8mmol/L.
Drug: Placebo · Drug: Insulin · Drug: Glucose
Suspension administered orally for a treatment period of 24h. 2 sachets administered up to three times over 10h (at 0, 4 and 10h).
Suspension administered orally for a treatment period of 24h. Single dose contains 2 sachets of ZS 5g. 10g administered up to three times over 10h (at 0, 4 and 10h).
Also known as: ZS, ZS-9
Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.
Glucose 25g administered IV \<15 minutes before the insulin.
Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.
Glucose 25g administered IV \<15 minutes before the insulin.
Mean Absolute Change in S-K From Baseline Until 4h After Start of Dosing With SZC/Placebo
The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 4h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means.
Time frame: Baseline to 4h potassium measurements.
Fraction of Patients Responding to Therapy Defined as: S-K <6.0mmol/L Between 1 and 4h and S-K <5.0mmol/L at 4h; and no Additional Potassium Lowering Therapy From 0 to 4h With Exception of the Initial Insulin Treatment
Additional therapies for hyperkalaemia are 2nd dose of insulin, Beta-agonists, Diuretics, Dialysis, Sodium bicarbonate and Potassium binders when administered with the expressed intent to lower S-K. Patients with any missing potassium value from 1h to 4h inclusive will be treated as non-responders.
Time frame: Baseline to 4h potassium meansurements.
The Fraction of Patients Achieving Normokalaemia 1, 2 and 4h After Start of Dosing With SZC/Placebo
Proportion of patients achieving normokalaemia, S-K 3.5-5.0 mmol/L, at 1, 2 and 4h after start of dosing
Time frame: Baseline to 4h potassium meansurements.
The Fraction of Patients Achieving S-K <5.5mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo
Time frame: Baseline to 4h potassium meansurements.
The Fraction of Patients Achieving S-K <6.0mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo
Time frame: Baseline to 4h potassium meansurements.
The Fraction of Patients Administered Additional Potassium Lowering Therapy Due to Hyperkalaemia From 0 to 4h.
Additional therapies for hyperkalaemia are 2nd dose of insulin, Beta-agonists, Diuretics, Dialysis, Sodium bicarbonate and Potassium binders when administered with the expressed intent to lower S-K.
Time frame: Baseline to 4h potassium meansurements.
Mean Absolute Change in S-K From Baseline to 1h and 2h After Start of Dosing With SZC/Placebo
The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 1h and 2h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means.
Time frame: Baseline to 2h potassium measurements.
Participants took part in the study in the United States, Russia, Denmark and Italy from 13 February 2018 to 21 December 2018.
| Milestone | Sodium Zirconium Cyclosilicate (SZC) 10g | Placebo |
|---|---|---|
| Started | 33 | 37 |
| Completed | 22 | 24 |
| Not completed | 11 | 13 |
| Withdrew: Not categorized into the listed ones | 11 | 9 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 2 |
Additional therapies for hyperkalaemia are 2nd dose of insulin, Beta-agonists, Diuretics, Dialysis, Sodium bicarbonate and Potassium binders when administered with the expressed intent to lower S-K. Patients with any missing potassium value from 1h to 4h inclusive will be treated as non-responders.
| Proportion of participants | Sodium Zirconium Cyclosilicate (SZC) 10g | Placebo |
|---|---|---|
| Fraction of Patients Responding to Therapy Defined as: S-K <6.0mmol/L Between 1 and 4h and S-K <5.0mmol/L at 4h; and no Additional Potassium Lowering Therapy From 0 to 4h With Exception of the Initial Insulin Treatment | 0.063 | 0.056 |
Proportion of patients achieving normokalaemia, S-K 3.5-5.0 mmol/L, at 1, 2 and 4h after start of dosing
| Proportion of participants | Sodium Zirconium Cyclosilicate (SZC) 10g | Placebo |
|---|---|---|
| 1h | 0.156 | 0.139 |
| 2h | 0.125 | 0.056 |
| 4h | 0.063 | 0.056 |
| Proportion of paticipants | Sodium Zirconium Cyclosilicate (SZC) 10g | Placebo |
|---|---|---|
| 1h | 0.313 | 0.306 |
| 2h | 0.375 | 0.167 |
| 4h | 0.156 | 0.139 |
| Proportion of paticipants | Sodium Zirconium Cyclosilicate (SZC) 10g | Placebo |
|---|---|---|
| 1h | 0.656 | 0.611 |
| 2h | 0.625 | 0.472 |
| 4h | 0.469 | 0.361 |
Additional therapies for hyperkalaemia are 2nd dose of insulin, Beta-agonists, Diuretics, Dialysis, Sodium bicarbonate and Potassium binders when administered with the expressed intent to lower S-K.
| Proportion of participants | Sodium Zirconium Cyclosilicate (SZC) 10g | Placebo |
|---|---|---|
| The Fraction of Patients Administered Additional Potassium Lowering Therapy Due to Hyperkalaemia From 0 to 4h. | 0.156 | 0.306 |
The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 1h and 2h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means.
| mmol/L | Sodium Zirconium Cyclosilicate (SZC) 10g | Placebo |
|---|---|---|
| 1h | -0.67 (-0.90 to -0.44) | -0.67 (-0.89 to -0.45) |
| 2h | -0.72 (-0.96 to -0.48) | -0.36 (-0.59 to -0.14) |
The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 4h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means.
| mmol/L | Sodium Zirconium Cyclosilicate (SZC) 10g | Placebo |
|---|---|---|
| Mean Absolute Change in S-K From Baseline Until 4h After Start of Dosing With SZC/Placebo | -0.41 (-0.63 to -0.19) | -0.27 (-0.48 to -0.07) |
Collected over AEs, including SAEs, were collected from time of signature of informed consent form throughout the treatment period and including the follow-up period (visit 2 or last contact). AE/SAEs occurring between 0h to 24h and AE/SAEs occurring after 24h (time calculated from the start of the administration of insulin) were analysed separately.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sodium Zirconium Cyclosilicate (SZC) 10g (0-24h) | 0/29 (0%) | 1/29 (3.4%) | 4/29 (13.8%) |
| Placebo (0-24h) | 1/33 (3%) | 2/33 (6.1%) | 5/33 (15.2%) |
| Sodium Zirconium Cyclosilicate (SZC) 10g (After 24h) | 0/29 (0%) | 2/29 (6.9%) | 3/29 (10.3%) |
| Placebo (After 24 h) | 0/33 (0%) | 3/33 (9.1%) | 0/33 (0%) |
| Event | Sodium Zirconium Cyclosilicate (SZC) 10g (0-24h) | Placebo (0-24h) | Sodium Zirconium Cyclosilicate (SZC) 10g (After 24h) | Placebo (After 24 h) |
|---|---|---|---|---|
| HyperkalaemiaMetabolism and nutrition disorders | 0/29 | 0/33 | 0/29 | 2/33 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/29 | 0/33 | 0/29 | 0/33 |
| Cardiac failureCardiac disorders | 0/29 | 0/33 | 1/29 | 0/33 |
| Tibia fractureInjury, poisoning and procedural complications | 0/29 | 0/33 | 1/29 | 0/33 |
| HypotensionVascular disorders | 0/29 | 1/33 | 0/29 | 0/33 |
| Clonic convulsionNervous system disorders | 0/29 | 1/33 | 0/29 | 0/33 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/29 | 1/33 | 0/29 | 0/33 |
| PneumoniaInfections and infestations | 0/29 | 0/33 | 0/29 | 1/33 |
| Event | Sodium Zirconium Cyclosilicate (SZC) 10g (0-24h) | Placebo (0-24h) | Sodium Zirconium Cyclosilicate (SZC) 10g (After 24h) | Placebo (After 24 h) |
|---|---|---|---|---|
| HypoglycaemiaMetabolism and nutrition disorders | 4/29 | 3/33 | 0/29 | 0/33 |
| NauseaGastrointestinal disorders | 1/29 | 2/33 | 2/29 | 0/33 |
| Procedural painInjury, poisoning and procedural complications | 0/29 | 0/33 | 2/29 | 0/33 |
| Age, Continuous(years) | Sodium Zirconium Cyclosilicate (SZC) 10g | Placebo | Total |
|---|---|---|---|
| Mean | 62.0 ± 12.7 | 56.4 ± 14.4 | 59.0 ± 13.8 |
| Age, Customized(Participants) | Sodium Zirconium Cyclosilicate (SZC) 10g | Placebo | Total |
|---|---|---|---|
| <50 years | 6 | 11 | 17 |
| >=50 - <65 years | 11 | 18 | 29 |
| >=65 years | 16 | 8 | 24 |
| Sex: Female, Male(Participants) | Sodium Zirconium Cyclosilicate (SZC) 10g | Placebo | Total |
|---|---|---|---|
| Female | 16 | 19 | 35 |
| Male | 17 | 18 | 35 |
| Ethnicity (NIH/OMB)(Participants) | Sodium Zirconium Cyclosilicate (SZC) 10g | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 10 | 16 |
| Not Hispanic or Latino | 27 | 27 | 54 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Sodium Zirconium Cyclosilicate (SZC) 10g | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 9 | 20 |
| White | 22 | 26 | 48 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(Participants) | Sodium Zirconium Cyclosilicate (SZC) 10g | Placebo | Total |
|---|---|---|---|
| Denmark | 0 | 2 | 2 |
| Italy | 1 | 1 | 2 |
| Russia | 13 | 14 | 27 |
| United States | 19 | 20 | 39 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Dec 2018, 10 months.
Results were first posted in Jan 2020, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium zirconium cyclosilicate