Trial · NCT03990363
A Study of Verinurad and Allopurinol in Patients With Chronic Kidney Disease and Hyperuricaemia
NCT03990363, Phase 2, Completed, AstraZeneca; results first posted 2023-03-02
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study of Verinurad and Allopurinol in Patients With Chronic Kidney Disease and Hyperuricaemia. Trials, record NCT03990363. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03990363
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Verinurad and Allopurinol in Patients With Chronic Kidney Disease and Hyperuricaemia
- NCT number
- NCT03990363
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 861 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Chronic Kidney Disease
- Interventions
- Verinurad, Allopurinol, Placebo for Verinurad, Placebo for Allopurinol
- First posted
- 2019-06-19
- Last updated
- 2023-03-02
- Results first posted
- 2023-03-02
- Limitations and caveats
The study was initially planned to be 108 weeks. However, following the implementation of the amendment in Protocol Version 5.0, all patients discontinued therapy after 60 weeks (Visit 10).~Subjects that were on Low dose at Visit 9 were switched to 24 mg dose.~The study was terminated in Mexico in March 2021.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Urinary Albumin to Creatinine Ratio (uACR) (mg/g) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM) | Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8) | Analyses of change from baseline in uACR at 6 months (Visit 8) focused on: * High dose vs Placebo * High dose and Inter. dose combined vs Allopurinol alone * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo For High dose and Inter. dose combined the 2 categories merged forming 1 new temporary category. |
| Secondary | Urinary Albumin to Creatinine Ratio (uACR) (mg/g) Change From Baseline at 12 Months (Visit 10), Repeated Measures Mixed Model (MMRM) | Baseline to 12 months (Visit 10); analysis at 12 months (Visit 10) | Change from baseline in uACR at 12 months (Visit 10) for comparison of Switch dose protocol version 5.0 (PA5) versus double-capsule Placebo. The statistical model applied was an MMRM, which was basically the same as the one applied in the primary analysis but adjusted for a 12 month horizon and adapted to the double-capsule regimen from Visit 9 on. |
| Secondary | Serum Uric Acid (sUA) (mg/dL) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM) | Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8) | Change from baseline in sUA at 6 months (Visit 8), there were 7 comparisons requested for each endpoint, namely: * High dose vs Placebo * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo. |
| Secondary | Serum Uric Acid (sUA) Change From Baseline at 12 Months (Visit 10), Repeated Measures Mixed Model (MMRM) | Baseline to 12 months (Visit 10); analysis at 12 months (Visit 10) | Change from baseline in sUA at 12 months (Visit 10) for comparison of Switch dose protocol version 5.0 (PA5) versus double-capsule Placebo. |
| Secondary | Estimated Glomerular Filtration Rate (eGFR) (mL/Min/1.73 m²) Change From Baseline at 6 Months (V8), Repeated Measures Mixed Model (MMRM) | Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8) | Change from baseline in eGFR at 6 months (Visit 8), there were 7 comparisons requested for this endpoint, namely: * High dose vs Placebo * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo. |
| Secondary | Estimated Glomerular Filtration Rate (eGFR) (mL/Min/1.73 m²) Change From Baseline at 12 Months (Visit 10) | Change from baseline to 12 months (Visit 10) | Change from baseline in eGFR at 12 months (Visit 10) for the following treatments: * High Dose * Inter. Dose * Low Dose (a) * Switch Dose protocol version 5.0 (PA5) (b) * Allopurinol * Placebo 1. Subjects that switched from Verinurad 3 mg to Verinurad 24 mg at Visit 9 are not included in this group for Visit 10. 2. Contains all subjects randomized to the low dose group that later switched to Verinurad 24 mg plus Allopurinol 300 mg. |
| Secondary | S-creatinine (mg/dL) Change From Baseline at 6 Months (V8), Repeated Measures Mixed Model (MMRM) | Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8) | Change from baseline in S-creatinine at 6 months (Visit 8), there were 7 comparisons requested for this endpoint, namely: * High dose vs Placebo * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo. |
| Secondary | S-creatinine (mg/dL) Change From Baseline at 12 Months (Visit 10) | Change from baseline to 12 months (Visit 10) | Change from baseline in S-creatinine at 12 months (Visit 10) for the following treatments: * High Dose * Inter. Dose * Low Dose (a) * Switch Dose protocol version 5.0 (PA5) (b) * Allopurinol * Placebo 1. Subjects that switched from Verinurad 3 mg to Verinurad 24 mg at Visit 9 are not included in this group for Visit 10. 2. Contains all subjects randomized to the low dose group that later switched to Verinurad 24 mg plus Allopurinol 300 mg. |
| Secondary | P-cystatin C (mg/L) Change From Baseline at 6 Months (V8), Repeated Measures Mixed Model (MMRM) | Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8) | Change from baseline in P-cystatin C at 6 months (Visit 8), there were 7 comparisons requested for this endpoint, namely: * High dose vs Placebo * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo. |
| Secondary | P-cystatin C (mg/L) Change From Baseline at 12 Months (Visit 10) | Change from baseline to 12 months (Visit 10) | Change from baseline in S-creatinine at 12 months (Visit 10) for the following treatments: * High Dose * Inter. Dose * Low Dose (a) * Switch Dose protocol version 5.0 (PA5) (b) * Allopurinol * Placebo 1. Subjects that switched from Verinurad 3 mg to Verinurad 24 mg at Visit 9 are not included in this group for Visit 10. 2. Contains all subjects randomized to the low dose group that later switched to Verinurad 24 mg plus Allopurinol 300 mg. |
Source ClinicalTrials.gov
Outcomes10
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) (mg/g) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM) | Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8) | Full analysis set (evaluable participant included only)~In the primary endpoint the arms are presented as comparisons of treatment groups with either placebo or allopurinol alone.~Geometric mean ratio is presented between arms as a pre-specified analysis. | mg/g | GEOMETRIC_MEAN |
| SECONDARY | Urinary Albumin to Creatinine Ratio (uACR) (mg/g) Change From Baseline at 12 Months (Visit 10), Repeated Measures Mixed Model (MMRM) | Baseline to 12 months (Visit 10); analysis at 12 months (Visit 10) | Full analysis set (evaluable participant included only)~In this secondary endpoint the arm presented provides a comparison between the Switch Dose group and double-capsule placebo at Visit 10. This is a pre-specified analysis between the Switch Dose group and double-capsule placebo at Visit 10.~Geometric mean ratio is presented between arms as a pre-specified analysis. | mg/g | GEOMETRIC_MEAN |
| SECONDARY | Serum Uric Acid (sUA) (mg/dL) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM) | Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8) | Full analysis set (evaluable participant included only)~In this secondary endpoint the arms are presented as comparisons of treatment groups with either placebo or allopurinol alone.~Geometric mean ratio is presented between arms as a pre-specified analysis. | mg/dL | GEOMETRIC_MEAN |
| SECONDARY | Serum Uric Acid (sUA) Change From Baseline at 12 Months (Visit 10), Repeated Measures Mixed Model (MMRM) | Baseline to 12 months (Visit 10); analysis at 12 months (Visit 10) | Full analysis set (evaluable participant included only)~In this secondary endpoint the arm presented provides a comparison between the Switch Dose group and double-capsule placebo at Visit 10. This is a pre-specified analysis between the Switch Dose group and double-capsule placebo at Visit 10.~Geometric mean ratio is presented between arms as a pre-specified analysis. | mg/dL | GEOMETRIC_MEAN |
| SECONDARY | Estimated Glomerular Filtration Rate (eGFR) (mL/Min/1.73 m²) Change From Baseline at 6 Months (V8), Repeated Measures Mixed Model (MMRM) | Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8) | Full analysis set (evaluable participant included only)~In this secondary endpoint the arms are presented as comparisons of treatment groups with either placebo or allopurinol alone.~Geometric mean ratio is presented between arms as a pre-specified analysis. | mL/min/1.73 m² | GEOMETRIC_MEAN |
| SECONDARY | Estimated Glomerular Filtration Rate (eGFR) (mL/Min/1.73 m²) Change From Baseline at 12 Months (Visit 10) | Change from baseline to 12 months (Visit 10) | Full analysis set (evaluable participant included only) | mL/min/1.73 m² | GEOMETRIC_MEAN |
| SECONDARY | S-creatinine (mg/dL) Change From Baseline at 6 Months (V8), Repeated Measures Mixed Model (MMRM) | Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8) | Full analysis set (evaluable participant included only)~In this secondary endpoint the arms are presented as comparisons of treatment groups with either placebo or allopurinol alone.~Geometric mean ratio is presented between arms as a pre-specified analysis. | Geometric Mean Ratio | GEOMETRIC_MEAN |
| SECONDARY | S-creatinine (mg/dL) Change From Baseline at 12 Months (Visit 10) | Change from baseline to 12 months (Visit 10) | Full analysis set (evaluable participant included only) | mg/dL | GEOMETRIC_MEAN |
| SECONDARY | P-cystatin C (mg/L) Change From Baseline at 6 Months (V8), Repeated Measures Mixed Model (MMRM) | Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8) | Full analysis set (evaluable participant included only)~In this secondary endpoint the arms are presented as comparisons of treatment groups with either placebo or allopurinol alone.~Geometric mean ratio is presented between arms as a pre-specified analysis. | Geometric Mean Ratio | GEOMETRIC_MEAN |
| SECONDARY | P-cystatin C (mg/L) Change From Baseline at 12 Months (Visit 10) | Change from baseline to 12 months (Visit 10) | Full analysis set (evaluable participant included only) | mg/L | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group56
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) (mg/g) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM) | High Dose Versus Placebo | 0.8300 | 95% Confidence Interval 0.6810 to 1.012 | mg/g | |
| Urinary Albumin to Creatinine Ratio (uACR) (mg/g) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM) | High Dose and Intermediate Dose Combined Versus Allopurinol | 1.043 | 95% Confidence Interval 0.8793 to 1.237 | mg/g | |
| Urinary Albumin to Creatinine Ratio (uACR) (mg/g) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM) | Intermediate Dose Versus Placebo | 0.8369 | 95% Confidence Interval 0.6887 to 1.017 | mg/g | |
| Urinary Albumin to Creatinine Ratio (uACR) (mg/g) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM) | Low Dose Versus Placebo | 0.8499 | 95% Confidence Interval 0.6984 to 1.034 | mg/g | |
| Urinary Albumin to Creatinine Ratio (uACR) (mg/g) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM) | High Dose Versus Allopurinol | 1.037 | 95% Confidence Interval 0.8506 to 1.265 | mg/g | |
| Urinary Albumin to Creatinine Ratio (uACR) (mg/g) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM) | Intermediate Dose Versus Allopurinol | 1.046 | 95% Confidence Interval 0.8603 to 1.272 | mg/g | |
| Urinary Albumin to Creatinine Ratio (uACR) (mg/g) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM) | Low Dose Versus Allopurinol | 1.062 | 95% Confidence Interval 0.8725 to 1.293 | mg/g | |
| Urinary Albumin to Creatinine Ratio (uACR) (mg/g) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM) | Allopurinol Versus Placebo | 0.8001 | 95% Confidence Interval 0.6573 to 0.9739 | mg/g | |
| Urinary Albumin to Creatinine Ratio (uACR) (mg/g) Change From Baseline at 12 Months (Visit 10), Repeated Measures Mixed Model (MMRM) | Switch Dose PA5 Versus Placebo | 1.016 | 95% Confidence Interval 0.7437 to 1.388 | mg/g | |
| Serum Uric Acid (sUA) (mg/dL) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM) | High Dose Versus Placebo | 0.5098 | 95% Confidence Interval 0.4701 to 0.5528 | mg/dL |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | High Dose | 172 | |
| Overall Study | STARTED | Intermediate Dose | 172 | |
| Overall Study | STARTED | Low Dose | 173 | |
| Overall Study | STARTED | Allopurinol | 171 | |
| Overall Study | STARTED | Placebo | 173 | |
| Overall Study | Switch Dose | High Dose | 0 | |
| Overall Study | Switch Dose | Intermediate Dose | 0 | |
| Overall Study | Switch Dose | Low Dose | 37 | |
| Overall Study | Switch Dose | Allopurinol | 0 | |
| Overall Study | Switch Dose | Placebo | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,008
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 | Headache | Nervous system disorders | High Dose | 8 | 172 | 9 |
| other | Headache | Nervous system disorders | Intermediate Dose | 4 | 172 | 4 |
| other | Headache | Nervous system disorders | Low Dose | 6 | 172 | 6 |
| other | Headache | Nervous system disorders | Switch Dose | 0 | 37 | 0 |
| other | Headache | Nervous system disorders | Allopurinol | 3 | 171 | 4 |
| other | Headache | Nervous system disorders | Placebo | 11 | 173 | 13 |
| other | Hypertension | Vascular disorders | High Dose | 6 | 172 | 6 |
| other | Hypertension | Vascular disorders | Intermediate Dose | 9 | 172 | 12 |
| other | Hypertension | Vascular disorders | Low Dose | 5 | 172 | 7 |
| other | Hypertension | Vascular disorders | Switch Dose | 0 | 37 | 0 |
1 to 10 of 1,008Source ClinicalTrials.gov
See all 1,008 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High Dose | 14 | 172 |
| Total, all-cause mortality | Intermediate Dose | 8 | 172 |
| Total, all-cause mortality | Low Dose | 13 | 172 |
| Total, all-cause mortality | Switch Dose | 1 | 37 |
| Total, all-cause mortality | Allopurinol | 10 | 171 |
| Total, all-cause mortality | Placebo | 11 | 173 |
| Total, other adverse events | High Dose | 32 | 172 |
| Total, other adverse events | Intermediate Dose | 32 | 172 |
| Total, other adverse events | Low Dose | 28 | 172 |
| Total, other adverse events | Switch Dose | 1 | 37 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
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.
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