Trial · NCT03118739
Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With Albuminuria
NCT03118739, Phase 2, Completed, AstraZeneca; results first posted 2020-01-10
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With Albuminuria. Trials, record NCT03118739. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03118739
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With Albuminuria
- NCT number
- NCT03118739
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Hyperuricemia, Albuminuria, Type 2 Diabetes
- Interventions
- Verinurad 9 mg+Febuxostat 80 mg, Placebo
- First posted
- 2017-04-18
- Last updated
- 2020-01-10
- Results first posted
- 2020-01-10
- Limitations and caveats
The treatment code was broken for 3 patients.The effect of verinurad/febuxostat on sUA was underestimated as drug was administered after collection of blood samples.3 patients treated with verinurad/febuxostat had no detectable drug in PK samples.
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Urinary Albumin to Creatinine Ratio (UACR) | From Baseline to 12 Weeks of Treatment | LS Mean Percentage Change (95% CI) from Baseline in UACR |
| Primary | Urinary Albumin to Creatinine Ratio (UACR) Compared to Placebo | From Baseline to 24 Weeks of Treatment | LS Mean Percentage Change (90% CI) from Baseline in UACR Compared to Placebo |
| Primary | Urinary Albumin to Creatinine Ratio (UACR) | From Baseline to 24 Weeks of Treatment | LS Mean Percentage Change (95% CI) from Baseline in UACR |
| Secondary | sUA | From Baseline to 12 Weeks and 24 Weeks of Treatment | LS Mean Percentage Change (95% CI) from Baseline in sUA |
| Secondary | eGFR | From Baseline to 12 Weeks and 24 Weeks of Treatment | LS Mean Percentage Change (95% CI) from Baseline in eGFR |
| Secondary | Serum Creatinine | From Baseline to 12 Weeks and 24 Weeks of Treatment | LS Mean Percentage Change (95% CI) from Baseline in Serum Creatinine |
| Secondary | Serum Cystatin C | From Baseline to 12 Weeks and 24 Weeks of Treatment | LS Mean Percentage Change (95% CI) from Baseline in Serum Cystatin C |
| Secondary | Serum High Sensitivity C-reactive Protein | From Baseline to 12 Weeks and 24 Weeks of Treatment | LS Mean Percentage Change (95% CI) from Baseline in Serum High Sensitivity C-reactive Protein |
| Secondary | Clinical Assessments | From Baseline to 12 Weeks and 24 Weeks of Treatment | Change from Baseline in Diastolic and Systolic Blood Pressure |
| Secondary | MRI Variables - LV Mass/End-diastolic Volume | From Baseline to 24 Weeks of Treatment | Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline) |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes43
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Urinary Albumin to Creatinine Ratio (UACR) | From Baseline to 12 Weeks of Treatment | Number analyzed at 12 weeks was less than the overall number analyzed due to missing observations | Precent change | LEAST_SQUARES_MEAN |
| SECONDARY | sUA | From Baseline to 12 Weeks and 24 Weeks of Treatment | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | eGFR | From Baseline to 12 Weeks and 24 Weeks of Treatment | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Serum Creatinine | From Baseline to 12 Weeks and 24 Weeks of Treatment | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Serum Cystatin C | From Baseline to 12 Weeks and 24 Weeks of Treatment | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Serum High Sensitivity C-reactive Protein | From Baseline to 12 Weeks and 24 Weeks of Treatment | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Assessments | From Baseline to 12 Weeks and 24 Weeks of Treatment | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | mm/Hg | MEAN |
| SECONDARY | MRI Variables - LV Mass/End-diastolic Volume | From Baseline to 24 Weeks of Treatment | Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations | g/mL | MEAN |
| OTHER_PRE_SPECIFIED | Flow Mediated Dilatation (Reactive Hyperemia) | From Baseline to 12 Weeks and 24 Weeks of Treatment | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | Units on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Urinalysis | From Baseline to 12 Weeks and 24 Weeks of Treatment | Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations | mg/dL | MEAN |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 outcomesResults by group168
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Urinary Albumin to Creatinine Ratio (UACR) | Verinurad 9 mg+Febuxostat 80 mg | -48.65 | 95% Confidence Interval -64.807 to -25.089 | Precent change | |
| Urinary Albumin to Creatinine Ratio (UACR) | Placebo | -15.31 | 95% Confidence Interval -43.244 to 26.370 | Precent change | |
| sUA | Verinurad 9 mg+Febuxostat 80 mg | 12 weeks | -56.81 | 95% Confidence Interval -63.879 to -48.350 | Percent change |
| sUA | Placebo | 12 weeks | 6.86 | 95% Confidence Interval -11.800 to 29.471 | Percent change |
| sUA | Verinurad 9 mg+Febuxostat 80 mg | 24 weeks | -61.93 | 95% Confidence Interval -68.274 to -54.319 | Percent change |
| sUA | Placebo | 24 weeks | 4.73 | 95% Confidence Interval -13.795 to 27.239 | Percent change |
| eGFR | Verinurad 9 mg+Febuxostat 80 mg | 12 weeks | 1.25 | 95% Confidence Interval -6.520 to 9.674 | Percent change |
| eGFR | Placebo | 12 weeks | -4.40 | 95% Confidence Interval -12.258 to 4.154 | Percent change |
| eGFR | Verinurad 9 mg+Febuxostat 80 mg | 24 weeks | -1.73 | 95% Confidence Interval -9.446 to 6.648 | Percent change |
| eGFR | Placebo | 24 weeks | 0.55 | 95% Confidence Interval -7.854 to 9.712 | Percent change |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Verinurad 9 mg+Febuxostat 80 mg | 32 | |
| Overall Study | STARTED | Placebo | 28 | |
| Overall Study | Completed 12 Weeks of Treatment | Verinurad 9 mg+Febuxostat 80 mg | 26 | |
| Overall Study | Completed 12 Weeks of Treatment | Placebo | 25 | |
| Overall Study | Completed 24 Weeks of Treatment | Verinurad 9 mg+Febuxostat 80 mg | 24 | |
| Overall Study | Completed 24 Weeks of Treatment | Placebo | 25 | |
| Overall Study | COMPLETED | Verinurad 9 mg+Febuxostat 80 mg | 25 | |
| Overall Study | COMPLETED | Placebo | 24 | |
| Overall Study | NOT COMPLETED | Verinurad 9 mg+Febuxostat 80 mg | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events28
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 | Verinurad 9 mg+Febuxostat 80 mg | 4 | 32 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 28 | 1 |
| other | Nasopharyngitis | Infections and infestations | Verinurad 9 mg+Febuxostat 80 mg | 2 | 32 | 2 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 1 | 28 | 1 |
| other | Dizziness | Nervous system disorders | Verinurad 9 mg+Febuxostat 80 mg | 3 | 32 | 3 |
| other | Dizziness | Nervous system disorders | Placebo | 0 | 28 | 0 |
| serious | Acute Myocardial Infarction | Cardiac disorders | Verinurad 9 mg+Febuxostat 80 mg | 0 | 32 | 0 |
| serious | Acute Myocardial Infarction | Cardiac disorders | Placebo | 1 | 28 | 1 |
| serious | Cardiac Failure Congestive | Cardiac disorders | Verinurad 9 mg+Febuxostat 80 mg | 0 | 32 | 0 |
| serious | Cardiac Failure Congestive | Cardiac disorders | Placebo | 1 | 28 | 1 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Verinurad 9 mg+Febuxostat 80 mg | 0 | 32 |
| Total, all-cause mortality | Placebo | 0 | 28 |
| Total, other adverse events | Verinurad 9 mg+Febuxostat 80 mg | 9 | 32 |
| Total, other adverse events | Placebo | 2 | 28 |
| Total, serious adverse events | Verinurad 9 mg+Febuxostat 80 mg | 5 | 32 |
| Total, serious adverse events | Placebo | 3 | 28 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Verinurad 9 mg+Febuxostat 80 mg vs Placebo: deaths from any cause | Trial comparisons |
| Verinurad 9 mg+Febuxostat 80 mg vs Placebo: serious adverse events | 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.
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/NCT03118739
GET https://conductscience.org/api/trials/v1/NCT03118739/registered?page=2