A Phase 3 interventional study of Placebo and Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia, sponsored by AstraZeneca. Completed at 53 sites in 4 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by AstraZeneca · Phase 3, 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 8th largest by enrollment, is one of 4 that started in 2017, is one of 12 in phase 3, and was the 7th 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. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 196 is above 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.
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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 10th largest by enrollment of the 24 interventional ones that give a count, is one of 6 that started in 2017, is one of 13 in phase 3, and was the 13th 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 purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia in patients on hemodialysis.
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.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of ZS 5g depending on dose level assigned to a patient per non-dialysis days.
Drug: Sodium Zirconium Cyclosilicate (ZS)
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of Placebo depending on dose level assigned to a patient per non-dialysis days.
Drug: Placebo
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) . Single dose contains from 1 to 3 sachets of Placebo depending on dose level assigned to a patient per non-dialysis days.
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) . Single dose contains from 1 to 3 sachets of ZS 5g depending on dose level assigned to a patient per non-dialysis days.
Percentage of Responders
A subject was considered to be a responder if, during the evaluation period, they maintained a pre-dialysis serum potassium (S-K) between 4.0 and 5.0 mmol/L on at least 3 out of 4 dialysis treatments following the long inter-dialytic interval and did not receive rescue therapy. The S-K levels used for this analysis were based on the measurements obtained by the central laboratory.
Time frame: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15.
Percentage of Responders When Accounting for Missing Central Laboratory Serum Potassium Data
The sensitivity analysis assessed the impact of subjects classified as non-responders due to missing serum potassium (S-K) data. Missing central lab (c-lab) pre-dialysis values were imputed using corresponding pre-dialysis i-STAT (a portable blood analyser) measurements. In addition, a "last observation carried forward" (LOCF) approach was utilized to further impute missing values of pre-dialysis S-K during the evaluation period. This technique will replace missing c-lab S-K values with the last available non-missing pre-dialysis LIDI observation recorded for that patient (and this could be a c-lab value or an imputed c-lab value). The Primary endpoint analysis was repeated on the imputed data.
Time frame: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15.
Percentage of Patients Needing Rescue Therapy
Patients requiring any urgent intervention consistent with local practice patterns to reduce serum potassium (S-K) including insulin/glucose, beta-adrenergic agonists, sodium bicarbonate, K binders or any form of renal replacement therapy.
Time frame: An 8 week overall treatment period (a 4 week adjustment phase plus a 4 week evaluation phase) and a 2 week follow up period.
| Milestone | Sodium Zirconium Cyclosilicate (SZC) | Placebo |
|---|---|---|
| Started | 97 | 99 |
| Completed | 92 | 96 |
| Not completed | 5 | 3 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Kidney transplantation | 0 | 1 |
| Withdrew: Investigational product discontinuation | 0 | 1 |
| Withdrew: Transferred to non-study dialysis center | 1 | 0 |
| Withdrew: Non-comliance to study protocol | 0 | 1 |
| Withdrew: Adverse event | 1 | 0 |
A subject was considered to be a responder if, during the evaluation period, they maintained a pre-dialysis serum potassium (S-K) between 4.0 and 5.0 mmol/L on at least 3 out of 4 dialysis treatments following the long inter-dialytic interval and did not receive rescue therapy. The S-K levels used for this analysis were based on the measurements obtained by the central laboratory.
| Percentage of participants | Sodium Zirconium Cyclosilicate (SZC) | Placebo |
|---|---|---|
| Percentage of Responders | 41.2 | 1.0 |
Patients requiring any urgent intervention consistent with local practice patterns to reduce serum potassium (S-K) including insulin/glucose, beta-adrenergic agonists, sodium bicarbonate, K binders or any form of renal replacement therapy.
| Percentage of participants | Sodium Zirconium Cyclosilicate (SZC) | Placebo |
|---|---|---|
| Percentage of Patients Needing Rescue Therapy | 2.1 | 5.1 |
The sensitivity analysis assessed the impact of subjects classified as non-responders due to missing serum potassium (S-K) data. Missing central lab (c-lab) pre-dialysis values were imputed using corresponding pre-dialysis i-STAT (a portable blood analyser) measurements. In addition, a "last observation carried forward" (LOCF) approach was utilized to further impute missing values of pre-dialysis S-K during the evaluation period. This technique will replace missing c-lab S-K values with the last available non-missing pre-dialysis LIDI observation recorded for that patient (and this could be a c-lab value or an imputed c-lab value). The Primary endpoint analysis was repeated on the imputed data.
| Percentage of participants | Sodium Zirconium Cyclosilicate (SZC) | Placebo |
|---|---|---|
| Percentage of Responders When Accounting for Missing Central Laboratory Serum Potassium Data | 42.3 | 2.0 |
Collected over Adverse Events will be collected from time of randomization throughout the treatment period and including the follow-up period (until Visit 16 or the last patient visit in the study), up to 10 weeks (Day 71 +/- 3 days). SAEs will be recorded from the time of informed consent.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sodium Zirconium Cyclosilicate (SZC) | 1/96 (1%) | 7/96 (7.3%) | 7/96 (7.3%) |
| Placebo | 0/99 (0%) | 8/99 (8.1%) | 11/99 (11.1%) |
| Event | Sodium Zirconium Cyclosilicate (SZC) | Placebo |
|---|---|---|
| HyperkalaemiaMetabolism and nutrition disorders | 1/96 | 3/99 |
| Angina pectorisCardiac disorders | 2/96 | 0/99 |
| Fluid overloadMetabolism and nutrition disorders | 0/96 | 2/99 |
| GangreneInfections and infestations | 1/96 | 0/99 |
| Gastroenteritis viralInfections and infestations | 1/96 | 0/99 |
| Peripheral arterial occlusive diseaseVascular disorders | 1/96 | 0/99 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/96 | 1/99 |
| Small intestinal obstructionGastrointestinal disorders | 1/96 | 0/99 |
| Arteriovenous fistula occlusionInjury, poisoning and procedural complications | 1/96 | 0/99 |
| BacteraemiaInfections and infestations | 0/96 | 1/99 |
| Event | Sodium Zirconium Cyclosilicate (SZC) | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 4/96 | 6/99 |
| NasopharyngitisInfections and infestations | 3/96 | 5/99 |
| Age, Continuous(Years) | Sodium Zirconium Cyclosilicate (SZC) | Placebo | Total |
|---|---|---|---|
| Mean | 55.7 ± 13.84 | 60.4 ± 13.2 | 58.1 ± 13.69 |
| Sex: Female, Male(Participants) | Sodium Zirconium Cyclosilicate (SZC) | Placebo | Total |
|---|---|---|---|
| Female | 40 | 41 | 81 |
| Male | 57 | 58 | 115 |
| Race/Ethnicity, Customized(Participants) | Sodium Zirconium Cyclosilicate (SZC) | Placebo | Total |
|---|---|---|---|
| White | 50 | 52 | 102 |
| Black Or African American | 11 | 8 | 19 |
| Asian | 33 | 33 | 66 |
| American Indian Or Alasa Native | 1 | 2 | 3 |
| Other | 2 | 4 | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Nov 2018, 10 months.
Results were first posted in Feb 2020, 1 year 3 months after primary completion.
Of 18 phase 3 interventional studies under Hyperkalemia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 29. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 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