HyperuricemiaPhase 2NCT03118739

Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With Albuminuria

A Phase 2 study testing Verinurad 9 mg+Febuxostat 80 mg in people with Hyperuricemia and Albuminuria, run by AstraZeneca at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this clinical research study is to evaluate signals of potential clinical benefit of the combination of Verinurad and Febuxostat in lowering concentrations of circulating uric acid and thus improving kidney or cardiovascular status of patients with hyperuricemia, albuminuria, and Type 2 diabetes (T2DM). Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Hyperuricemia, Albuminuria, Type 2 Diabetes
What is being tested?: Verinurad 9 mg+Febuxostat 80 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 18 sitesUnited States
Study dates: 18 May 2017to 13 Aug 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Serum Uric Acid ≥6.0 mg/dL
eGFR ≥30 mL/min/1.73 m2
UACR between 30 mg/g and 3500 mg/g inclusive
Diagnosed with T2DM

Who cannot join

Treated with any drug for hyperuricemia in the 6 months preceding randomization.Drugs for hyperuricemia include all XO inhibitors (allopurinol, febuxostat and topiroxostat) and URAT1 inhibitors (lesinurad, verinurad, probenecid, and benzbromarone)
Prior history of gout, unless prophylaxis therapy isn't required
Patients who are pregnant, lactating, or planning to become pregnant
Patients unsuitable or unable to undergo MRI assessment

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Research Site
Canyon Country, California, 91351
Research Site
Chula Vista, California, 91911
Research Site
Corona, California, 92882
Research Site
Escondido, California, 92025
Research Site
Houston, Texas, 77058
Research Site
Houston, Texas, 77070
Research Site
Lakewood, California, 90805
Research Site
Lincoln, California, 95648
Research Site
Los Angeles, California, 90017
Research Site
Los Angeles, California, 90022
Research Site
Los Angeles, California, 90036
Research Site
North Hollywood, California, 91606
Research Site
Oceanside, California, 92056-4510
Research Site
Orange, California, 92868
Research Site
Pearland, Texas, 77584
Research Site
Sacramento, California, 95821
Research Site
Sugar Land, Texas, 77478
Research Site
Webster, Texas, 77598

Other trials in United States

About this study

Official title: Effects of Intensive Uric Acid Lowering Therapy With RDEA3170 (Verinurad) and Febuxostat in Patients With Albuminuria

Read the detailed description

Evidence shows independent associations between elevated serum uric acid (sUA) and the risk of hypertension, myocardial infarction (MI), chronic kidney disease (CKD), T2DM, heart failure (HF), and metabolic syndrome, including obesity. Gout is associated with an increased risk of all-cause death, as well as cardiovascular death. The causal relationship between elevated sUA, gout, and these disease outcomes remains to be proven.

Verinurad (RDEA3170), is a novel Urate Transporter 1 (URAT1) inhibitor in Phase II development. Verinurad combined with the xanthine oxidase (XO) inhibitor febuxostat has been shown to lower sUA in patients with recurrent gout in Phase II studies by >80%. The extensive lowering of sUA delivered by the combination presents a unique opportunity to explore whether intensive urate lowering therapy can improve kidney and/or cardiac health.

This study will assess if intensive serum urate lowering therapy, more potent than ever explored before in the chronic out-patient setting, can improve chronic kidney or cardiac function in the study population.

In order to maximize the scientific value of the study and minimize the risk for systemic biases a parallel group, double blind, randomized design will be utilized.

The study will recruit patients with hyperuricemia and presenting with albuminuria.

Hyperuricemic patients are expected to benefit more from urate lowering, and albuminuria at baseline is required, as the primary objective of the study will be to assess changes in albuminuria.

Patients are also required to be diagnosed with T2DM. Patients with T2DM frequently exhibit changes in cardiac function detectable using magnetic resonance imaging (MRI) that represents an early, pre-symptomatic state of HF. By limiting recruitment to patients with T2DM and by performing MRI at baseline and 6 months of therapy, the study will deliver insights into whether or not intensive urate lowering therapy can positively affect not only chronic kidney disease, but also cardiac disease.

Conditions: Hyperuricemia, Albuminuria, Type 2 Diabetes
Being tested: Verinurad 9 mg+Febuxostat 80 mg, Placebo
Medical subject headings: Hyperuricemia, Albuminuria, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Verinurad 9 mg+Febuxostat 80 mgDrug
Also called Verinurad (RDEA3170), Febuxostat(Uloric)
Capsule administered orally, once daily for 24 weeks
PlaceboDrug
Capsule administered orally, once daily for 24 weeks

Study groups in NCT03118739
Study group	Role	What they receive
Verinurad 9 mg+Febuxostat 80 mg	Experimental	Capsule administered orally, once daily for 24 weeks Receives: Drug: Verinurad 9 mg+Febuxostat 80 mg
Placebo	Placebo comparator	Capsule administered orally, once daily for 24 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Urinary Albumin to Creatinine Ratio (UACR)
LS Mean Percentage Change (95% CI) from Baseline in UACR
Measured: From Baseline to 12 Weeks of Treatment
Urinary Albumin to Creatinine Ratio (UACR) Compared to Placebo
LS Mean Percentage Change (90% CI) from Baseline in UACR Compared to Placebo
Measured: From Baseline to 24 Weeks of Treatment
Urinary Albumin to Creatinine Ratio (UACR)
LS Mean Percentage Change (95% CI) from Baseline in UACR
Measured: From Baseline to 24 Weeks of Treatment

Secondary outcomes (12)

sUA
LS Mean Percentage Change (95% CI) from Baseline in sUA
Measured: From Baseline to 12 Weeks and 24 Weeks of Treatment
eGFR
LS Mean Percentage Change (95% CI) from Baseline in eGFR
Measured: From Baseline to 12 Weeks and 24 Weeks of Treatment
Serum Creatinine
LS Mean Percentage Change (95% CI) from Baseline in Serum Creatinine
Measured: From Baseline to 12 Weeks and 24 Weeks of Treatment
Serum Cystatin C
LS Mean Percentage Change (95% CI) from Baseline in Serum Cystatin C
Measured: From Baseline to 12 Weeks and 24 Weeks of Treatment
Serum High Sensitivity C-reactive Protein
LS Mean Percentage Change (95% CI) from Baseline in Serum High Sensitivity C-reactive Protein
Measured: From Baseline to 12 Weeks and 24 Weeks of Treatment
Clinical Assessments
Change from Baseline in Diastolic and Systolic Blood Pressure
Measured: From Baseline to 12 Weeks and 24 Weeks of Treatment
MRI Variables - LV Mass/End-diastolic Volume
Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline)
Measured: From Baseline to 24 Weeks of Treatment
MRI Variables - Kidney Cortex T2 Star - BOLD MRI
Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline)
Measured: From Baseline to 24 Weeks of Treatment
MRI Variables - LV End-diastolic Volume, LV End-systolic Volume, LV Stroke Volume
Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline)
Measured: From Baseline to 24 Weeks of Treatment
MRI Variables - LV Ejection Fraction, Circumferential Strain, Longitudinal Strain, Radial Strain
Change from baseline in MRI Variables at Week 24 (CFB = Change from Baseline)
Measured: From Baseline to 24 Weeks of Treatment
MRI Variables - Diastolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate and Systolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate
Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline)
Measured: From Baseline to 24 Weeks of Treatment
MRI Variables - LV Mass
Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline)
Measured: From Baseline to 24 Weeks of Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 May 201713 Aug 2018

First posted18 Apr 2017
Study start18 May 2017
Primary completion13 Aug 2018
Study completion13 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HyperuricemiaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, double-blind, double-dummy, placebo-controlled, parallel, independent groups, repeated measures, multi-center study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03118739
Sponsor's protocol ID: D5495C00007
Status last verified: Dec 2019
First submitted: 12 Apr 2017
Last updated: 10 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Individual participant data (IPD) will likely not be shared with external collaborators/researchers as this data is planned to be used only for internal decision-making

Publications

Heerspink HJL, Stack AG, Terkeltaub R, Greene TA, Inker LA, Bjursell M, Perl S, Rikte T, Erlandsson F, Perkovic V. Rationale, design, demographics and baseline characteristics of the randomized, controlled, Phase 2b SAPPHIRE study of verinurad plus allopurinol in patients with chronic kidney disease and hyperuricaemia. Nephrol Dial Transplant. 2022 Jul 26;37(8):1461-1471. doi: 10.1093/ndt/gfab237.
PubMed 34383954
Stack AG, Dronamraju N, Parkinson J, Johansson S, Johnsson E, Erlandsson F, Terkeltaub R. Effect of Intensive Urate Lowering With Combined Verinurad and Febuxostat on Albuminuria in Patients With Type 2 Diabetes: A Randomized Trial. Am J Kidney Dis. 2021 Apr;77(4):481-489. doi: 10.1053/j.ajkd.2020.09.009. Epub 2020 Oct 29.
PubMed 33130235

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hyperuricemia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Intensive Uric Acid Lowering Therapy With RDEA3170 (Verinurad) and Febuxostat in Patients With Albuminuria
ClinicalTrials.gov ID: NCT03118739
Acronym / sponsor ID: D5495C00007
Conditions: Hyperuricemia, Albuminuria, Type 2 Diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 18 May 2017 (actual)
Primary completion: 13 Aug 2018 (actual)
Study completion: 13 Aug 2018 (actual)
First posted: 18 Apr 2017 (actual)
Results: Posted 10 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

In order to maximize the scientific value of the study and minimize the risk for systemic biases a parallel group, double blind, randomized design will be utilized.

The study will recruit patients with hyperuricemia and presenting with albuminuria.

Hyperuricemic patients are expected to benefit more from urate lowering, and albuminuria at baseline is required, as the primary objective of the study will be to assess changes in albuminuria.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized, double-blind, double-dummy, placebo-controlled, parallel, independent groups, repeated measures, multi-center study

Arm	Type	Receives
Verinurad 9 mg+Febuxostat 80 mg	Experimental	Drug: Verinurad 9 mg+Febuxostat 80 mgCapsule administered orally, once daily for 24 weeks
Placebo	Placebo comparator	Drug: PlaceboCapsule administered orally, once daily for 24 weeks

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Serum Uric Acid ≥6.0 mg/dL
eGFR ≥30 mL/min/1.73 m2
UACR between 30 mg/g and 3500 mg/g inclusive
Diagnosed with T2DM

Key exclusion criteria (4 listed)

Treated with any drug for hyperuricemia in the 6 months preceding randomization.Drugs for hyperuricemia include all XO inhibitors (allopurinol, febuxostat and topiroxostat) and URAT1 inhibitors (lesinurad, verinurad, probenecid, and benzbromarone)
Prior history of gout, unless prophylaxis therapy isn't required
Patients who are pregnant, lactating, or planning to become pregnant
Patients unsuitable or unable to undergo MRI assessment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Verinurad 9 mg+Febuxostat 80 mgAlso: Verinurad (RDEA3170), Febuxostat(Uloric)Capsule administered orally, once daily for 24 weeks	Drug	Verinurad 9 mg+Febuxostat 80 mg
PlaceboCapsule administered orally, once daily for 24 weeks	Drug	Placebo

Primary outcome

Urinary Albumin to Creatinine Ratio (UACR)
Time frame: From Baseline to 12 Weeks of Treatment
LS Mean Percentage Change (95% CI) from Baseline in UACR
Urinary Albumin to Creatinine Ratio (UACR) Compared to Placebo
Time frame: From Baseline to 24 Weeks of Treatment
LS Mean Percentage Change (90% CI) from Baseline in UACR Compared to Placebo
Urinary Albumin to Creatinine Ratio (UACR)
Time frame: From Baseline to 24 Weeks of Treatment
LS Mean Percentage Change (95% CI) from Baseline in UACR

12 secondary outcomes

sUA
Time frame: From Baseline to 12 Weeks and 24 Weeks of Treatment
eGFR
Time frame: From Baseline to 12 Weeks and 24 Weeks of Treatment
Serum Creatinine
Time frame: From Baseline to 12 Weeks and 24 Weeks of Treatment
Serum Cystatin C
Time frame: From Baseline to 12 Weeks and 24 Weeks of Treatment
Serum High Sensitivity C-reactive Protein
Time frame: From Baseline to 12 Weeks and 24 Weeks of Treatment
Clinical Assessments
Time frame: From Baseline to 12 Weeks and 24 Weeks of Treatment
MRI Variables - LV Mass/End-diastolic Volume
Time frame: From Baseline to 24 Weeks of Treatment
MRI Variables - Kidney Cortex T2 Star - BOLD MRI
Time frame: From Baseline to 24 Weeks of Treatment
MRI Variables - LV End-diastolic Volume, LV End-systolic Volume, LV Stroke Volume
Time frame: From Baseline to 24 Weeks of Treatment
MRI Variables - LV Ejection Fraction, Circumferential Strain, Longitudinal Strain, Radial Strain
Time frame: From Baseline to 24 Weeks of Treatment
MRI Variables - Diastolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate and Systolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate
Time frame: From Baseline to 24 Weeks of Treatment
MRI Variables - LV Mass
Time frame: From Baseline to 24 Weeks of Treatment

Results and safety

Results posted to the registry on 10 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Verinurad 9 mg+Febuxostat 80 mg	32	25
Placebo	28	24

Primary outcome: Urinary Albumin to Creatinine Ratio (UACR)

Time frame: From Baseline to 12 Weeks of Treatment. Least squares mean (95% Confidence Interval). Unit: Precent change

Measure	Verinurad 9 mg+Febuxostat 80 mg n = 32	Placebo n = 28
Value	-48.65 (-64.807 to -25.089)	-15.31 (-43.244 to 26.370)

Verinurad 9 mg+Febuxostat 80 mg vs Placebo: Mean % Change from Baseline: -39.37 (90% CI -61.785 to -3.814)

Population analysed: Number analyzed at 12 weeks was less than the overall number analyzed due to missing observations

Primary outcome: Urinary Albumin to Creatinine Ratio (UACR) Compared to Placebo

Time frame: From Baseline to 24 Weeks of Treatment. Least squares mean (90% Confidence Interval). Unit: Precent change

Measure	Verinurad 9 mg+Febuxostat 80 mg n = 32	Placebo n = 28
Value	-49.26 (-68.206 to -19.009)	NA (NA to NA)

Population analysed: Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations

Primary outcome: Urinary Albumin to Creatinine Ratio (UACR)

Time frame: From Baseline to 24 Weeks of Treatment. Least squares mean (95% Confidence Interval). Unit: Precent change

Measure	Verinurad 9 mg+Febuxostat 80 mg n = 32	Placebo n = 28
Value	-38.40 (-58.051 to -9.535)	21.40 (-18.948 to 81.829)

Population analysed: Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from time of signature of informed consent (Screening Visit) throughout the treatment period and including the follow-up period (Day 190).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Verinurad 9 mg+Febuxostat 80 mg	5 of 32 (15.6%)	9 of 32 (28.1%)	0 of 32
Placebo	3 of 28 (10.7%)	2 of 28 (7.1%)	0 of 28

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34383954Heerspink HJL, Stack AG, Terkeltaub R, Greene TA, Inker LA, Bjursell M, Perl S, Rikte T, Erlandsson F, Perkovic V. Rationale, design, demographics and baseline characteristics of the randomized, controlled, Phase 2b SAPPHIRE study of verinurad plus allopurinol in patients with chronic kidney disease and hyperuricaemia. Nephrol Dial Transplant. 2022 Jul 26;37(8):1461-1471. doi: 10.1093/ndt/gfab237.
Derived from this study: PubMed 33130235Stack AG, Dronamraju N, Parkinson J, Johansson S, Johnsson E, Erlandsson F, Terkeltaub R. Effect of Intensive Urate Lowering With Combined Verinurad and Febuxostat on Albuminuria in Patients With Type 2 Diabetes: A Randomized Trial. Am J Kidney Dis. 2021 Apr;77(4):481-489. doi: 10.1053/j.ajkd.2020.09.009. Epub 2020 Oct 29.
Redacted ProtocolLink provided by the sponsor.
redacted SAPLink provided by the sponsor.
Individual participant dataSharing planned: No. Individual participant data (IPD) will likely not be shared with external collaborators/researchers as this data is planned to be used only for internal decision-making

Related trials for Hyperuricemia

Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Verinurad 9 mg+Febuxostat 80 mg in people with Hyperuricemia and Albuminuria, run by AstraZeneca at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary Albumin to Creatinine Ratio (UACR) (time frame: From Baseline to 12 Weeks of Treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03118739, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.