Trial · NCT04724837
Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)
NCT04724837, Phase 2, Completed, AstraZeneca; results first posted 2024-07-30
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial). Trials, record NCT04724837. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04724837
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)
- NCT number
- NCT04724837
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 542 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Chronic Kidney Disease
- Interventions
- Zibotentan, Dapagliflozin, Placebo
- First posted
- 2021-01-26
- Last updated
- 2024-07-30
- Other registries' IDs
- eudract:2020-004101-32
- Results first posted
- 2024-07-30
- Limitations and caveats
- No multiple testing correction was considered in this early phase study.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12 | From baseline (Week 0 [Day 1]) until Week 12 (Day 84) | The effect of zibotentan 1.5/dapagliflozin 10 mg versus dapagliflozin 10 mg on UACR was assessed. |
| Secondary | Change in UACR From Baseline to Week 12 | From baseline (Week 0 [Day 1]) until Week 12 | The effect of zibotentan 0.25 mg/dapagliflozin 10 mg versus dapagliflozin 10 mg monotherapy on UACR was assessed. |
| Secondary | Change in Office Systolic Blood Pressure From Baseline to Week 12 | From baseline (Week 0 [Day 1]) until Week 12 (Day 84) | The change in office systolic blood pressure for doses of zibotentan combined with dapagliflozin 10 mg versus dapagliflozin 10 mg monotherapy was assessed. |
| Secondary | Change in Office Diastolic Blood Pressure From Baseline to Week 12 | From baseline (Week 0 [Day 1]) until Week 12 (Day 84) | The change in office diastolic blood pressure for doses of zibotentan combined with dapagliflozin 10 mg versus dapagliflozin 10 mg monotherapy was assessed. |
| Secondary | Change in UACR From Baseline to Week 12 | From baseline (Week 0 [Day 1]) until Week 12 (Day 84) | The assessment of dose-response and relationship across different dose of zibotentan/dapagliflozin and dapagliflozin alone on UACR reduction. |
| Secondary | Change in eGFR From Baseline to Week 1, Week 12, and Week 14 | From baseline (Week 0 [Day 1]) until Week 1 (Day 8), Week 12 (Day 84), and Week 14 (Day 98) | The effect of different doses of zibotentan and dapagliflozin 10 mg in combination versus dapagliflozin 10 mg monotherapy on eGFR was assessed. |
| Secondary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | From Screening (Day -28) until Follow-up visit (Day 98), up to 126 days | The safety and tolerability of all doses of zibotentan combined with dapagliflozin 10 mg and dapagliflozin 10 mg monotherapy was assessed. |
| Secondary | Change in eGFR From Week 1 to Week 12 | From Week 1 (Day 8) to Week 12 (Day 84) | The effect of different doses of zibotentan and dapagliflozin 10 mg in combination versus dapagliflozin 10 mg monotherapy on eGFR was assessed. |
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 | Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12 | From baseline (Week 0 [Day 1]) until Week 12 (Day 84) | The full analysis set included all participants who were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints. | milligram/gram (mg/g) | GEOMETRIC_MEAN |
| SECONDARY | Change in UACR From Baseline to Week 12 | From baseline (Week 0 [Day 1]) until Week 12 | The full analysis set included all participants who were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints. | mg/g | GEOMETRIC_MEAN |
| SECONDARY | Change in Office Systolic Blood Pressure From Baseline to Week 12 | From baseline (Week 0 [Day 1]) until Week 12 (Day 84) | The full analysis set included all participants who were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints. | Millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change in Office Diastolic Blood Pressure From Baseline to Week 12 | From baseline (Week 0 [Day 1]) until Week 12 (Day 84) | The full analysis set included all participants who were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints. | mmHg | MEAN |
| SECONDARY | Change in UACR From Baseline to Week 12 | From baseline (Week 0 [Day 1]) until Week 12 (Day 84) | The full analysis set included all participants who were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints. | mg/g | GEOMETRIC_MEAN |
| SECONDARY | Change in eGFR From Baseline to Week 1, Week 12, and Week 14 | From baseline (Week 0 [Day 1]) until Week 1 (Day 8), Week 12 (Day 84), and Week 14 (Day 98) | The full analysis set included all participants who were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints. | milliliters/minutes/1.73 square metres | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | From Screening (Day -28) until Follow-up visit (Day 98), up to 126 days | The safety analysis set included all participants that were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in eGFR From Week 1 to Week 12 | From Week 1 (Day 8) to Week 12 (Day 84) | The full analysis set included all participants who were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints. | milliliters/minutes/1.73 square metres | MEAN |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12 | Zibotentan 1.5 mg + Dapagliflozin | 0.48 | Standard Error 1.094 | milligram/gram (mg/g) | |
| Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12 | Placebo + Dapagliflozin | 0.72 | Standard Error 1.090 | milligram/gram (mg/g) | |
| Change in UACR From Baseline to Week 12 | Zibotentan 0.25 mg + Dapagliflozin | 0.52 | Standard Error 1.106 | mg/g | |
| Change in UACR From Baseline to Week 12 | Placebo + Dapagliflozin | 0.72 | Standard Error 1.090 | mg/g | |
| Change in Office Systolic Blood Pressure From Baseline to Week 12 | Zibotentan 0.25 mg + Dapagliflozin | -7.1 | 90% Confidence Interval -10.0 to -4.1 | Millimeters of mercury (mmHg) | |
| Change in Office Systolic Blood Pressure From Baseline to Week 12 | Zibotentan 1.5 mg + Dapagliflozin | -11.0 | 90% Confidence Interval -13.5 to -8.4 | Millimeters of mercury (mmHg) | |
| Change in Office Systolic Blood Pressure From Baseline to Week 12 | Placebo + Dapagliflozin | -3.4 | 90% Confidence Interval -5.8 to -1.0 | Millimeters of mercury (mmHg) | |
| Change in Office Diastolic Blood Pressure From Baseline to Week 12 | Zibotentan 0.25 mg + Dapagliflozin | -4.3 | 90% Confidence Interval -6.2 to -2.5 | mmHg | |
| Change in Office Diastolic Blood Pressure From Baseline to Week 12 | Zibotentan 1.5 mg + Dapagliflozin | -6.8 | 90% Confidence Interval -8.4 to -5.2 | mmHg | |
| Change in Office Diastolic Blood Pressure From Baseline to Week 12 | Placebo + Dapagliflozin | -1.4 | 90% Confidence Interval -2.9 to 0.1 | mmHg |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zibotentan 0.25 mg + Dapagliflozin | 91 | |
| Overall Study | STARTED | Zibotentan 1.5 mg + Dapagliflozin | 179 | |
| Overall Study | STARTED | Placebo + Dapagliflozin | 177 | |
| Overall Study | Full Analysis Set | Zibotentan 0.25 mg + Dapagliflozin | 91 | |
| Overall Study | Full Analysis Set | Zibotentan 1.5 mg + Dapagliflozin | 179 | |
| Overall Study | Full Analysis Set | Placebo + Dapagliflozin | 177 | |
| Overall Study | Safety Analysis Set | Zibotentan 0.25 mg + Dapagliflozin | 91 | |
| Overall Study | Safety Analysis Set | Zibotentan 1.5 mg + Dapagliflozin | 179 | |
| Overall Study | Safety Analysis Set | Placebo + Dapagliflozin | 177 | |
| Overall Study | COMPLETED | Zibotentan 0.25 mg + Dapagliflozin | 82 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events63
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 | Metabolic acidosis | Metabolism and nutrition disorders | Zibotentan 0.25 mg + Dapagliflozin | 5 | 91 | 5 |
| other | Metabolic acidosis | Metabolism and nutrition disorders | Zibotentan 1.5 mg + Dapagliflozin | 7 | 179 | 8 |
| other | Metabolic acidosis | Metabolism and nutrition disorders | Placebo + Dapagliflozin | 2 | 177 | 2 |
| other | Headache | Nervous system disorders | Zibotentan 0.25 mg + Dapagliflozin | 6 | 91 | 6 |
| other | Headache | Nervous system disorders | Zibotentan 1.5 mg + Dapagliflozin | 8 | 179 | 9 |
| other | Headache | Nervous system disorders | Placebo + Dapagliflozin | 2 | 177 | 2 |
| other | Hypertension | Vascular disorders | Zibotentan 0.25 mg + Dapagliflozin | 5 | 91 | 5 |
| other | Hypertension | Vascular disorders | Zibotentan 1.5 mg + Dapagliflozin | 0 | 179 | 0 |
| other | Hypertension | Vascular disorders | Placebo + Dapagliflozin | 1 | 177 | 1 |
| other | Brain natriuretic peptide increased | Investigations | Zibotentan 0.25 mg + Dapagliflozin | 2 | 91 | 2 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zibotentan 0.25 mg + Dapagliflozin | 0 | 91 |
| Total, all-cause mortality | Zibotentan 1.5 mg + Dapagliflozin | 0 | 179 |
| Total, all-cause mortality | Placebo + Dapagliflozin | 1 | 177 |
| Total, other adverse events | Zibotentan 0.25 mg + Dapagliflozin | 14 | 91 |
| Total, other adverse events | Zibotentan 1.5 mg + Dapagliflozin | 24 | 179 |
| Total, other adverse events | Placebo + Dapagliflozin | 6 | 177 |
| Total, serious adverse events | Zibotentan 0.25 mg + Dapagliflozin | 2 | 91 |
| Total, serious adverse events | Zibotentan 1.5 mg + Dapagliflozin | 10 | 179 |
| Total, serious adverse events | Placebo + Dapagliflozin | 4 | 177 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT04724837
GET https://conductscience.org/api/trials/v1/NCT04724837/results?page=2