Trial · NCT04727528
Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease
NCT04727528, Phase 3, Terminated, AstraZeneca; results first posted 2023-10-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease. Trials, record NCT04727528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04727528
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease
- NCT number
- NCT04727528
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 39 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Hyperkalaemia, Metabolic Acidosis, Chronic Kidney Disease
- Interventions
- Sodium zirconium cyclosilicate, Placebo
- First posted
- 2021-01-27
- Last updated
- 2023-10-06
- Results first posted
- 2023-10-06
- Limitations and caveats
Due to a screening failure rate higher than expected which led to early termination of the study, only 39 (17.0%) patients entered the open-label phase. Due to the early termination of the study and small sample size, the study was underpowered for the secondary efficacy endpoints.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence (Yes/no) of Participants Having Normal Serum Potassium (sK+) Between 3.5 and 5.0 mmol/L Inclusive at End of Treatment (EOT) Without Need for Rescue Treatment for Hyperkalemia at Any Point During the Randomized Phase | Day 1 of randomization phase to Day 29 | Response was defined as a subject having serum potassium (sK+) within 3.5-5.0 mmol/L at the EOT visit, and no use of rescue therapy for hyperkalaemia at any point during the randomized placebo-controlled period. Participants who used rescue therapy for hyperkalaemia at any point during the randomized placebo-controlled period were assigned a non-response. Participants who died prior to the EOT visit were treated as non-response. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. |
| Secondary | Mean Serum Bicarbonate at Day 29 | Day 29 | Least-squares mean calculated with a repeated measures analysis of covariance model where the dependent variable was post randomization serum bicarbonate and with fixed terms for randomized treatment group and serum bicarbonate. |
| Secondary | Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 3 mmol/L From Baseline to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) | Day 1 to Day 29 of randomization phase | Occurrence (yes/no) of participants having an increase in serum bicarbonate of greater than or equal to 3 mmol/L from baseline (Day 1) to EOT (Day 29) without need for rescue treatment for metabolic acidosis (low bicarbonate). Response was defined as a participant with an increase in serum bicarbonate greater than or equal to 3 mmol/L at the EOT visit without the need for rescue therapy for low bicarbonate. Participants who used rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period had their last observation prior to rescue therapy carried forward. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response. |
| Secondary | Occurrence (Yes/no) of Participants Having Serum Bicarbonate ≥22 mmol/L | Day 1 to Day 29 of randomization phase | Response was defined as a participant with an increase in serum bicarbonate greater than or equal to 22 mmol/L at the EOT visit without the need for rescue therapy for low bicarbonate. Participants who had used rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period had their last observation prior to rescue therapy carried forward. Participants who died prior to the EOT visit were assigned a non-response. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor. |
| Secondary | Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 2 mmol/L From Baseline (Day 1) to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) | Day 1 to Day 29 of randomization phase | Response was defined as a participant with an increase in serum bicarbonate greater than or equal to 2 mmol/L at the EOT visit and no use of rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period. Participants who used rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period had their last observation prior to rescue therapy carried forward. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response. |
| Secondary | Participants Having Normal sK+ at EOT and an Increase in Serum Bicarbonate of ≥3 mmol/L From Baseline Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) or Hyperkalemia | Day 1 to Day 29 of randomization phase | Participants with normal sK+ between 3.5 and 5.0 mmol/L inclusive at EOT and increase in serum bicarbonate greater than or equal to 3 mmol/L from Day 1 without rescue treatment for metabolic acidosis (low bicarbonate) or hyperkalemia. Response was a participant with sK+ within 3.5-5.0 mmol/L and increase in serum bicarbonate greater than or equal to 3 mmol/L at the EOT visit and no use of rescue therapy for hyperkalaemia or low bicarbonate at any point during the randomized placebo-controlled period. Participants who used rescue therapy for low bicarbonate or HK during the randomized placebo-controlled period had last observation prior to rescue therapy carried forward. Participants lost to follow-up prior to EOT visit had response as missing. Logistic regression model included response status (response/non-response) as dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response. |
| Secondary | Occurrence (Yes/no) of Patients Having a Normal sK+ Between 3.5 and 5.0 mmol/L Inclusive and Bicarbonate ≥22 mmol/L at Day 29 Without Need for Rescue Treatment for Hyperkalemia or Metabolic Acidosis (Low Bicarbonate) | Day 1 to Day 29 of randomization phase | Response was defined as a participant with sK+ within 3.5-5.0 mmol/L and serum bicarbonate greater than or equal to 22 mmol/L at the EOT visit without the need for rescue therapy for hyperkalaemia or low bicarbonate. Participants who used rescue therapy for hyperkalaemia or low bicarbonate at any point during the randomized placebo-controlled period were assigned a non-response. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response. |
| Secondary | Occurrence (Yes/no) of Participants Needing Rescue Treatment for Low Sodium Bicarbonate | Day 1 to Day 29 of randomization phase | Occurrence (yes/no) of participants needing rescue treatment for low sodium bicarbonate any time during the randomized phase |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Occurrence (Yes/no) of Participants Having Normal Serum Potassium (sK+) Between 3.5 and 5.0 mmol/L Inclusive at End of Treatment (EOT) Without Need for Rescue Treatment for Hyperkalemia at Any Point During the Randomized Phase | Day 1 of randomization phase to Day 29 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Serum Bicarbonate at Day 29 | Day 29 | Full analysis set | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 3 mmol/L From Baseline to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) | Day 1 to Day 29 of randomization phase | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence (Yes/no) of Participants Having Serum Bicarbonate ≥22 mmol/L | Day 1 to Day 29 of randomization phase | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 2 mmol/L From Baseline (Day 1) to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) | Day 1 to Day 29 of randomization phase | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Having Normal sK+ at EOT and an Increase in Serum Bicarbonate of ≥3 mmol/L From Baseline Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) or Hyperkalemia | Day 1 to Day 29 of randomization phase | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence (Yes/no) of Patients Having a Normal sK+ Between 3.5 and 5.0 mmol/L Inclusive and Bicarbonate ≥22 mmol/L at Day 29 Without Need for Rescue Treatment for Hyperkalemia or Metabolic Acidosis (Low Bicarbonate) | Day 1 to Day 29 of randomization phase | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence (Yes/no) of Participants Needing Rescue Treatment for Low Sodium Bicarbonate | Day 1 to Day 29 of randomization phase | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Occurrence (Yes/no) of Participants Having Normal Serum Potassium (sK+) Between 3.5 and 5.0 mmol/L Inclusive at End of Treatment (EOT) Without Need for Rescue Treatment for Hyperkalemia at Any Point During the Randomized Phase | Sodium Zirconium Cyclosilicate (SZC) | No response | 1 | Participants | |
Occurrence (Yes/no) of Participants Having Normal Serum Potassium (sK+) Between 3.5 and 5.0 mmol/L Inclusive at End of Treatment (EOT) Without Need for Rescue Treatment for Hyperkalemia at Any Point During the Randomized Phase | Placebo | No response | 15 | Participants | |
Occurrence (Yes/no) of Participants Having Normal Serum Potassium (sK+) Between 3.5 and 5.0 mmol/L Inclusive at End of Treatment (EOT) Without Need for Rescue Treatment for Hyperkalemia at Any Point During the Randomized Phase | Sodium Zirconium Cyclosilicate (SZC) | Response | 15 | Participants | |
Occurrence (Yes/no) of Participants Having Normal Serum Potassium (sK+) Between 3.5 and 5.0 mmol/L Inclusive at End of Treatment (EOT) Without Need for Rescue Treatment for Hyperkalemia at Any Point During the Randomized Phase | Placebo | Response | 4 | Participants | |
Occurrence (Yes/no) of Participants Having Normal Serum Potassium (sK+) Between 3.5 and 5.0 mmol/L Inclusive at End of Treatment (EOT) Without Need for Rescue Treatment for Hyperkalemia at Any Point During the Randomized Phase | Sodium Zirconium Cyclosilicate (SZC) | Missing | 1 | Participants | |
Occurrence (Yes/no) of Participants Having Normal Serum Potassium (sK+) Between 3.5 and 5.0 mmol/L Inclusive at End of Treatment (EOT) Without Need for Rescue Treatment for Hyperkalemia at Any Point During the Randomized Phase | Placebo | Missing | 1 | Participants | |
| Mean Serum Bicarbonate at Day 29 | Sodium Zirconium Cyclosilicate (SZC) | 18.17 | Standard Error 0.58 | mmol/L | |
| Mean Serum Bicarbonate at Day 29 | Placebo | 16.52 | Standard Error 0.56 | mmol/L | |
Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 3 mmol/L From Baseline to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) | Sodium Zirconium Cyclosilicate (SZC) | No response | 10 | Participants | |
Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 3 mmol/L From Baseline to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) | Placebo | No response | 16 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label Period | STARTED | Sodium Zirconium Cyclosilicate (SZC) | 39 | |
| Open-label Period | STARTED | Placebo | 0 | |
| Open-label Period | COMPLETED | Sodium Zirconium Cyclosilicate (SZC) | 37 | |
| Open-label Period | COMPLETED | Placebo | 0 | |
| Open-label Period | NOT COMPLETED | Sodium Zirconium Cyclosilicate (SZC) | 2 | |
| Open-label Period | NOT COMPLETED | Placebo | 0 | |
| Double-blind Treatment Phase | STARTED | Sodium Zirconium Cyclosilicate (SZC) | 17 | |
| Double-blind Treatment Phase | STARTED | Placebo | 20 | |
| Double-blind Treatment Phase | COMPLETED | Sodium Zirconium Cyclosilicate (SZC) | 16 | |
| Double-blind Treatment Phase | COMPLETED | Placebo | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events78
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Open-Label Phase | 1 | 38 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Sodium Zirconium Cyclosilicate (SZC) Double-blind Treatment Phase | 0 | 17 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Double-blind Treatment Phase | 1 | 20 | 2 |
| other | Nausea | Gastrointestinal disorders | Open-Label Phase | 0 | 38 | 0 |
| other | Nausea | Gastrointestinal disorders | Sodium Zirconium Cyclosilicate (SZC) Double-blind Treatment Phase | 0 | 17 | 0 |
| other | Nausea | Gastrointestinal disorders | Placebo Double-blind Treatment Phase | 2 | 20 | 2 |
| other | Oedema peripheral | General disorders | Open-Label Phase | 0 | 38 | 0 |
| other | Oedema peripheral | General disorders | Sodium Zirconium Cyclosilicate (SZC) Double-blind Treatment Phase | 0 | 17 | 0 |
| other | Oedema peripheral | General disorders | Placebo Double-blind Treatment Phase | 1 | 20 | 1 |
| other | Peripheral swelling | General disorders | Open-Label Phase | 0 | 38 | 0 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-Label Phase | 0 | 38 |
| Total, all-cause mortality | Sodium Zirconium Cyclosilicate (SZC) Double-blind Treatment Phase | 0 | 17 |
| Total, all-cause mortality | Placebo Double-blind Treatment Phase | 1 | 20 |
| Total, other adverse events | Open-Label Phase | 1 | 38 |
| Total, other adverse events | Sodium Zirconium Cyclosilicate (SZC) Double-blind Treatment Phase | 4 | 17 |
| Total, other adverse events | Placebo Double-blind Treatment Phase | 9 | 20 |
| Total, serious adverse events | Open-Label Phase | 0 | 38 |
| Total, serious adverse events | Sodium Zirconium Cyclosilicate (SZC) Double-blind Treatment Phase | 1 | 17 |
| Total, serious adverse events | Placebo Double-blind Treatment Phase | 2 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38622759 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04727528
GET https://conductscience.org/api/trials/v1/NCT04727528/results?page=2