Trial · NCT05056727
A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia
NCT05056727, Phase 3, Terminated, AstraZeneca; results first posted 2026-01-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia. Trials, record NCT05056727. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05056727
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia
- NCT number
- NCT05056727
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,112 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Renal Insufficiency, Chronic, Hyperkalemia
- Interventions
- Sodium Zirconium Cyclosilicate (SZC), Placebo, Lisinopril, Valsartan, Irbesartan
- First posted
- 2021-09-24
- Last updated
- 2026-01-08
- Other registries' IDs
- eudract:2021-001911-96
- Results first posted
- 2026-01-08
- Limitations and caveats
The study was terminated early due to recruitment challenges (not safety concerns). The ensuing small number of fully evaluable subjects (716 randomized vs planned 1360) and short follow up (mean 8 - 9 months vs planned 24 months) had a heavy negative impact on the formal statistical analyses, especially slope analyses, and therefore preclude any meaningful conclusions on eGFR slopes.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total eGFR Slope (Coprimary Analysis #1) | Baseline (Maintenance phase) to visit 17 (week 69) | Total eGFR slope, Baseline (Maintenance phase) to visit 17 (week 69) |
| Primary | Chronic eGFR Slope (Coprimary Analysis #2) | 12 weeks to visit 17 (week 69) | Chronic eGFR slope, 12 weeks to visit 17 (week 69) |
| Secondary | Incidence of the Composite of Kidney Failure Outcomes | From Baseline (Maintenance phase) up to week 97 (Maintenance phase) | Incidence of the composite of kidney failure outcomes comprising: sustained ≥ 40% decline in eGFR, onset of ESKD, and death from kidney failure is analyzed based on Cox regression model. Patients with no events are censored at end of maintenance phase or premature discontinuation. |
| Secondary | Incidence of RAASi Reduction | From Baseline (Maintenance phase) up to week 97 (Maintenance phase) | Incidence of RAASi (lisinopril/valsartan) dose decrease is analyzed based on Cox regression model. Patients with no events are censored at end of maintenance phase or premature discontinuation. |
| Secondary | UACR | At visit 13 (week 24) | Urine albumin-to-creatinine ratio (UACR); mass concentration of albumin divided by mass concentration of creatinine, in urine; at visit 13 (week 24) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total eGFR Slope (Coprimary Analysis #1) | Baseline (Maintenance phase) to visit 17 (week 69) | Full analysis set. | mL/min/(1.73 m2)/yr | LEAST_SQUARES_MEAN |
| PRIMARY | Chronic eGFR Slope (Coprimary Analysis #2) | 12 weeks to visit 17 (week 69) | Full analysis set. | mL/min/(1.73 m2)/yr | LEAST_SQUARES_MEAN |
| SECONDARY | Incidence of the Composite of Kidney Failure Outcomes | From Baseline (Maintenance phase) up to week 97 (Maintenance phase) | Full analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of RAASi Reduction | From Baseline (Maintenance phase) up to week 97 (Maintenance phase) | Full analysis set. Subjects on Valsartan/Lisinopril (RAASi) at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | UACR | At visit 13 (week 24) | Full analysis set. | mg/g | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total eGFR Slope (Coprimary Analysis #1) | Maintenance Phase: SZC | -5.2975 | 95% Confidence Interval -6.6854 to -3.9097 | mL/min/(1.73 m2)/yr | |
| Total eGFR Slope (Coprimary Analysis #1) | Maintenance Phase: Placebo | -4.5622 | 95% Confidence Interval -5.9969 to -3.1275 | mL/min/(1.73 m2)/yr | |
| Chronic eGFR Slope (Coprimary Analysis #2) | Maintenance Phase: SZC | -4.8705 | 95% Confidence Interval -6.7222 to -3.0189 | mL/min/(1.73 m2)/yr | |
| Chronic eGFR Slope (Coprimary Analysis #2) | Maintenance Phase: Placebo | -2.8285 | 95% Confidence Interval -4.7571 to -0.8999 | mL/min/(1.73 m2)/yr | |
| Incidence of the Composite of Kidney Failure Outcomes | Maintenance Phase: SZC | 7 | Participants | ||
| Incidence of the Composite of Kidney Failure Outcomes | Maintenance Phase: Placebo | 4 | Participants | ||
| Incidence of RAASi Reduction | Maintenance Phase: SZC | 55 | Participants | ||
| Incidence of RAASi Reduction | Maintenance Phase: Placebo | 128 | Participants | ||
| UACR | Maintenance Phase: SZC | 1513.07 | 95% Confidence Interval 1253.89 to 1772.24 | mg/g | |
| UACR | Maintenance Phase: Placebo | 1211.94 | 95% Confidence Interval 943.14 to 1480.74 | mg/g |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initiation Phase | STARTED | Initiation Phase | 1,112 | |
| Initiation Phase | STARTED | Run-in Phase | 0 | |
| Initiation Phase | STARTED | Maintenance Phase: SZC | 0 | |
| Initiation Phase | STARTED | Maintenance Phase: Placebo | 0 | |
| Initiation Phase | COMPLETED | Initiation Phase | 1,078 | |
| Initiation Phase | COMPLETED | Run-in Phase | 0 | |
| Initiation Phase | COMPLETED | Maintenance Phase: SZC | 0 | |
| Initiation Phase | COMPLETED | Maintenance Phase: Placebo | 0 | |
| Initiation Phase | NOT COMPLETED | Initiation Phase | 34 | |
| Initiation Phase | NOT COMPLETED | Run-in Phase | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events616
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 | Hypertension | Vascular disorders | Initiation Phase | 0 | 1,112 | 0 |
| other | Hypertension | Vascular disorders | Run-in Phase | 48 | 1,049 | 52 |
| other | Hypertension | Vascular disorders | Maintenance Phase: SZC | 18 | 359 | 19 |
| other | Hypertension | Vascular disorders | Maintenance Phase: Placebo | 13 | 355 | 15 |
| other | Hypotension | Vascular disorders | Initiation Phase | 0 | 1,112 | 0 |
| other | Hypotension | Vascular disorders | Run-in Phase | 18 | 1,049 | 21 |
| other | Hypotension | Vascular disorders | Maintenance Phase: SZC | 12 | 359 | 12 |
| other | Hypotension | Vascular disorders | Maintenance Phase: Placebo | 7 | 355 | 8 |
| other | Constipation | Gastrointestinal disorders | Initiation Phase | 3 | 1,112 | 3 |
| other | Constipation | Gastrointestinal disorders | Run-in Phase | 30 | 1,049 | 30 |
1 to 10 of 616Source ClinicalTrials.gov
See all 616 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Initiation Phase | 0 | 1,112 |
| Total, all-cause mortality | Run-in Phase | 3 | 1,049 |
| Total, all-cause mortality | Maintenance Phase: SZC | 4 | 359 |
| Total, all-cause mortality | Maintenance Phase: Placebo | 2 | 355 |
| Total, other adverse events | Initiation Phase | 12 | 1,112 |
| Total, other adverse events | Run-in Phase | 221 | 1,049 |
| Total, other adverse events | Maintenance Phase: SZC | 106 | 359 |
| Total, other adverse events | Maintenance Phase: Placebo | 120 | 355 |
| Total, serious adverse events | Initiation Phase | 0 | 1,112 |
| Total, serious adverse events | Run-in Phase | 56 | 1,049 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Maintenance Phase: SZC vs Maintenance Phase: Placebo: Incidence of RAASi Reduction | Trial comparisons |
| Maintenance Phase: SZC vs Maintenance Phase: Placebo: Incidence of the Composite of Kidney Failure Outcomes | Trial comparisons |
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/NCT05056727
GET https://conductscience.org/api/trials/v1/NCT05056727/flow?page=2