Asymptomatic HyperuricemiaPhase 2NCT03316131

A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UA

A Phase 2 study testing Verinurad, Febuxostat and Dapagliflozin in people with Asymptomatic Hyperuricemia, run by AstraZeneca at 2 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

This is a randomized, placebo controlled, double-blind, 2-way crossover study conducted on asymptomatic hyperuricemic patients. The core study consists of screening period, 2 treatment periods (verinurad + febuxostat + dapagliflozin/placebo) and follow-up visit Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Asymptomatic Hyperuricemia
What is being tested?: Verinurad, Febuxostat and Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 2 sitesUnited States
Study dates: 25 Oct 2017to 19 Jul 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

18 to 65 years old
Asymptomatic hyperuricemia (sUA > 6.0 mg/dL)
Body mass index between 18 and 35 kg/m2 inclusive and weight at least 50 kg and no more than 150 kg
Females must be non-pregnant, as well as post-menopausal or willing to use an acceptable method of contraception during the study.

Who cannot join

History of any clinically significant disease or disorder putting the patient at risk during the study, or influencing study results or ability to participate in the study
eGFR* < 45 mL/minute/1.73 m2 at Screening.
Type 2 diabetes mellitus with HbA1c >8%.
History of diabetic ketoacidosis, hyperosmolar non-ketotic coma, gout, or alcohol or drug abuse.
Ongoing treatment with an SGLT2-inhibitor, a URAT1-inhibitor, and/or a xanthine oxidase inhibitor.
Positive test for hepatitis B, hepatitis C or HIV.
Use of any medications in the 2 weeks preceding first administration of study drug.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Research Site
Baltimore, Maryland, 21225
Research Site
Glendale, California, 91206

Other trials in United States

About this study

Official title: Quantifying Uric Acid Excretion With RDEA3170, Febuxostat and Dapagliflozin

Read the detailed description

This is a randomized, placebo controlled, double-blind, 2-way crossover study to assess the effect of intensive UA lowering therapy with verinurad (RDEA3170), febuxostat, and dapagliflozin on urinary excretion of UA, in asymptomatic hyperuricemic patients. Thirty-six asymptomatic hyperuricemic patients aged 18 to 65 years (inclusive) will be enrolled into this study at 2 study centers. Twenty-four patients have been enrolled and completed the study to date. Due to inadequate urine sampling, 12 additional patients were included to ensure an adequate sample size (at least 20 evaluable patients) to evaluate the effects of intensive UA lowering with verinurad, febuxostat and dapagliflozin on urinary excretion of UA. With 24 completers available during the interim analysis, this will provide for a total sample size of 36 evaluable patients.

Before any study specific assessments are performed, potential patients must provide informed consent. Each patient will undergo the below mentioned visits:

A Screening period of maximum 28 days;
Two treatment periods during which patients will be resident in the Clinical Unit from Day -2 to Day 1 and from Day 6 to Day 8; and
A Follow-up Visit within 14 to 28 days after the first administration of Investigational Medicinal Product (IMP) in Treatment Period 2.

On Day -2 of Treatment period 1, patient will be randomized (1:1) to 1 of 2 treatment sequences (AB or BA). Each randomized patient will receive orally once daily fixed dose of the below mentioned 2 treatments for 7 consecutive days (1 treatment per treatment period).

Treatment A: Verinurad + febuxostat + dapagliflozin
Treatment B: Verinurad + febuxostat + placebo For each treatment period, baseline measurements will be performed. On Day 1, after all dosing and all assessments have been performed, patients will receive instruction to administer the IMP at home once daily in the morning from Day 2 to Day 6 and the IMP will be dispensed for home dosing. Patients will return to the Clinical Unit on Day 6 and will be residential in the Clinical Unit from Day 6 to Day 8.

Treatment Period 1 and Treatment Period 2 will be separated by a washout period of 7 to 21 days.

Patients will return to the Clinical Unit for a Follow-up Visit, 14 to 28 days after Day 1 of Treatment Period 2.

Conditions: Asymptomatic Hyperuricemia
Being tested: Verinurad, Febuxostat, Dapagliflozin, Dapagliflozin matched placebo
Keywords: Gout, Uric acid, Hyperuricemia, Asymptomatic gout, Febuxostat, Dapagliflozin, Uric acid transporter 1 (URAT1) Inhibitor, Xanthine Oxidase Inhibitor, Sodium-glucose cotransporter 2 (SGLT2) Inhibitor
Medical subject headings: Gout, Hyperuricemia

What participants receive

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

VerinuradDrug
Also called RDEA3170
Randomized patients will receive orally once daily fixed dose of verinurad in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo
FebuxostatDrug
Also called ULORIC
Randomized patients will receive orally once daily fixed dose of febuxostat in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo
DapagliflozinDrug
Also called FARXIGA
Randomized patients will receive orally once daily fixed dose of dapagliflozin in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo
Dapagliflozin matched placeboOther
Randomized patients will receive orally once daily fixed dose of dapagliflozin matched placebo in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo

Study groups in NCT03316131
Study group	Role	What they receive
Treatment A	Experimental	Randomized patients will receive orally once daily fixed dose of the following drugs: verinurad + febuxostat + dapagliflozin; Receives: Drug: Verinurad; Drug: Febuxostat; Drug: Dapagliflozin
Treatment B	Experimental	Randomized patients will receive orally once daily fixed dose of the following drugs: verinurad + febuxostat + dapagliflozin matched placebo Receives: Drug: Verinurad; Drug: Febuxostat; Other: Dapagliflozin matched placebo

What is being measured

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

Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7
Change from baseline in peak UA excretion during the first 8 hours on Day 7 of treatment to assess the effects of intensive UA lowering therapy with verinurad, febuxostat and dapagliflozin. Urine sample was collected in hourly intervals, and the highest amount of UA excreted in any interval was designated as peak UA excretion for each patient and treatment period.
Measured: On Day -1 and Day 7 of each treatment period
Change From Baseline in Plasma Concentration (Cmax) on Day 7
Cmax assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
Measured: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)
Change From Baseline in Area Under Plasma Concentration Time Curve From Time Zero to the Time of Last Measurable Concentration (AUClast) on Day 7
AUClast assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
Measured: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)
Change From Baseline in Area Under Plasma Concentration Time Curve Over a Dosing Interval (24 Hours) (AUCτ) on Day 7
AUCτ assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
Measured: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)

Secondary outcomes (3)

Change From Baseline in Urinary Excretion of Serum UA (sUA) on Day 7
Change from baseline in sUA to assess the intensive UA lowering effect of RDEA3170, febuxostat and dapagliflozin by evaluating the sUA levels after 7 days of treatment.
Measured: At Day -1 and Day 7
Change From Baseline in Time to Reach Maximum Observed Concentration (Tmax) on Day 7
tmax assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
Measured: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)
Change From Baseline in Time of Last Measurable Concentration (Tlast) on Day 7
tlast assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
Measured: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)

Timeline

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

25 Oct 201719 Jul 2018

First posted20 Oct 2017
Study start25 Oct 2017
Primary completion19 Jul 2018
Study completion19 Jul 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 (1)Papers the sponsor has linked to this study.
Other trials for Asymptomatic 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: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03316131
Sponsor's protocol ID: D5495C00001
Status last verified: Aug 2019
First submitted: 17 Oct 2017
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Stack AG, Han D, Goldwater R, Johansson S, Dronamraju N, Oscarsson J, Johnsson E, Parkinson J, Erlandsson F. Dapagliflozin Added to Verinurad Plus Febuxostat Further Reduces Serum Uric Acid in Hyperuricemia: The QUARTZ Study. J Clin Endocrinol Metab. 2021 Apr 23;106(5):e2347-e2356. doi: 10.1210/clinem/dgaa748.
PubMed 33075806

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 Asymptomatic Hyperuricemia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quantifying Uric Acid Excretion With RDEA3170, Febuxostat and Dapagliflozin
ClinicalTrials.gov ID: NCT03316131
Acronym / sponsor ID: D5495C00001
Conditions: Asymptomatic Hyperuricemia
Keywords: Gout, Uric acid, Hyperuricemia, Asymptomatic gout, Febuxostat, Dapagliflozin, Uric acid transporter 1 (URAT1) Inhibitor, Xanthine Oxidase Inhibitor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Contract Research Organization: USA, PAREXEL Early Phase Clinical Unit Baltimore, PAREXEL Early Phase Clinical Unit-Los Angeles, Clinical Laboratory: USA, Harbor Hospital Laboratory, GenX Laboratories Inc., Analytical Laboratory (Pharmacokinetic Sample Analysis): USA, Covance Bioanalytical Services, LLC
Study start: 25 Oct 2017 (actual)
Primary completion: 19 Jul 2018 (actual)
Study completion: 19 Jul 2018 (actual)
First posted: 20 Oct 2017 (actual)
Results: Posted 18 Jul 2019

Clinical summary

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

Detailed description

Before any study specific assessments are performed, potential patients must provide informed consent. Each patient will undergo the below mentioned visits:

A Screening period of maximum 28 days;
Two treatment periods during which patients will be resident in the Clinical Unit from Day -2 to Day 1 and from Day 6 to Day 8; and
A Follow-up Visit within 14 to 28 days after the first administration of Investigational Medicinal Product (IMP) in Treatment Period 2.

Treatment A: Verinurad + febuxostat + dapagliflozin
Treatment B: Verinurad + febuxostat + placebo For each treatment period, baseline measurements will be performed. On Day 1, after all dosing and all assessments have been performed, patients will receive instruction to administer the IMP at home once daily in the morning from Day 2 to Day 6 and the IMP will be dispensed for home dosing. Patients will return to the Clinical Unit on Day 6 and will be residential in the Clinical Unit from Day 6 to Day 8.

Treatment Period 1 and Treatment Period 2 will be separated by a washout period of 7 to 21 days.

Patients will return to the Clinical Unit for a Follow-up Visit, 14 to 28 days after Day 1 of Treatment Period 2.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Treatment A	Experimental	Drug: Verinurad, Drug: Febuxostat, Drug: DapagliflozinRandomized patients will receive orally once daily fixed dose of the following drugs: verinurad + febuxostat + dapagliflozin;
Treatment B	Experimental	Drug: Verinurad, Drug: Febuxostat, Other: Dapagliflozin matched placeboRandomized patients will receive orally once daily fixed dose of the following drugs: verinurad + febuxostat + dapagliflozin matched placebo

Who may qualify

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

Key inclusion criteria (4 listed)

18 to 65 years old
Asymptomatic hyperuricemia (sUA > 6.0 mg/dL)
Body mass index between 18 and 35 kg/m2 inclusive and weight at least 50 kg and no more than 150 kg
Females must be non-pregnant, as well as post-menopausal or willing to use an acceptable method of contraception during the study.

Key exclusion criteria (7 listed)

History of any clinically significant disease or disorder putting the patient at risk during the study, or influencing study results or ability to participate in the study
eGFR* < 45 mL/minute/1.73 m2 at Screening.
Type 2 diabetes mellitus with HbA1c >8%.
History of diabetic ketoacidosis, hyperosmolar non-ketotic coma, gout, or alcohol or drug abuse.
Ongoing treatment with an SGLT2-inhibitor, a URAT1-inhibitor, and/or a xanthine oxidase inhibitor.

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
VerinuradAlso: RDEA3170Randomized patients will receive orally once daily fixed dose of verinurad in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo	Drug	Treatment A, Treatment B
FebuxostatAlso: ULORICRandomized patients will receive orally once daily fixed dose of febuxostat in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo	Drug	Treatment A, Treatment B
DapagliflozinAlso: FARXIGARandomized patients will receive orally once daily fixed dose of dapagliflozin in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo	Drug	Treatment A
Dapagliflozin matched placeboRandomized patients will receive orally once daily fixed dose of dapagliflozin matched placebo in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo	Other	Treatment B

Primary outcome

Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7
Time frame: On Day -1 and Day 7 of each treatment period
Change from baseline in peak UA excretion during the first 8 hours on Day 7 of treatment to assess the effects of intensive UA lowering therapy with verinurad, febuxostat and dapagliflozin. Urine sample was collected in hourly intervals, and the highest amount of UA excreted in any interval was designated as peak UA excretion for each patient and treatment period.
Change From Baseline in Plasma Concentration (Cmax) on Day 7
Time frame: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)
Cmax assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
Change From Baseline in Area Under Plasma Concentration Time Curve From Time Zero to the Time of Last Measurable Concentration (AUClast) on Day 7
Time frame: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)
AUClast assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
Change From Baseline in Area Under Plasma Concentration Time Curve Over a Dosing Interval (24 Hours) (AUCτ) on Day 7
Time frame: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)
AUCτ assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin

3 secondary outcomes

Change From Baseline in Urinary Excretion of Serum UA (sUA) on Day 7
Time frame: At Day -1 and Day 7
Change From Baseline in Time to Reach Maximum Observed Concentration (Tmax) on Day 7
Time frame: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)
Change From Baseline in Time of Last Measurable Concentration (Tlast) on Day 7
Time frame: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)

Results and safety

Results posted to the registry on 18 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence A+B	18	18
Treatment Sequence B+A	18	18

Primary outcome: Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7

Time frame: On Day -1 and Day 7 of each treatment period. Least squares mean (95% Confidence Interval). Unit: milligrams (mg)

Measure	Treatment Sequence A+B n = 36	Treatment Sequence B+A n = 36
Value	-12.87 (-21.03 to -4.70)	-13.15 (-21.31 to -4.98)

Treatment Sequence A+B vs Treatment Sequence B+A: Mean Difference (Net): 0.28 (95% CI -8.67 to 9.22)

Population analysed: Protocol Analysis Set

Primary outcome: Change From Baseline in Plasma Concentration (Cmax) on Day 7

Time frame: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose). Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment Sequence A+B n = 36	Treatment Sequence B+A n = 36
Verinurad	17.52 (45.87)	15.26 (52.48)
M1	25.28 (41.55)	25.61 (57.24)
M8	18.45 (35.45)	18.42 (44.36)

Treatment Sequence A+B vs Treatment Sequence B+A: Geometric mean ratio: 1.14 (90% CI 1.03 to 1.25)
Treatment Sequence A+B vs Treatment Sequence B+A: Geometric mean ratio: 0.97 (90% CI 0.88 to 1.07)
Treatment Sequence A+B vs Treatment Sequence B+A: Geometric mean ratio: 0.99 (90% CI 0.91 to 1.08)

Population analysed: Pharmacokinetic Analysis Set

Primary outcome: Change From Baseline in Area Under Plasma Concentration Time Curve From Time Zero to the Time of Last Measurable Concentration (AUClast) on Day 7

Measure	Treatment Sequence A+B n = 36	Treatment Sequence B+A n = 36
Verinurad	149.1 (37.79)	141.0 (44.90)
M1	212.7 (42.74)	221.3 (49.13)
M8	174.2 (34.57)	176.5 (36.85)

Treatment Sequence A+B vs Treatment Sequence B+A: Geometric mean ratio: 1.06 (90% CI 1.00 to 1.13)
Treatment Sequence A+B vs Treatment Sequence B+A: Geometric mean ratio: 0.96 (90% CI 0.90 to 1.02)
Treatment Sequence A+B vs Treatment Sequence B+A: Geometric mean ratio: 0.99 (90% CI 0.94 to 1.04)

Population analysed: Pharmacokinetic Analysis Set

Primary outcome: Change From Baseline in Area Under Plasma Concentration Time Curve Over a Dosing Interval (24 Hours) (AUCτ) on Day 7

Measure	Treatment Sequence A+B n = 36	Treatment Sequence B+A n = 36
Verinurad	149.0 (37.84)	140.9 (44.90)
M1	212.6 (42.78)	221.1 (49.13)
M8	174.1 (34.59)	176.3 (36.81)

Treatment Sequence A+B vs Treatment Sequence B+A: Geometric mean ratio: 1.06 (90% CI 1.00 to 1.13)
Treatment Sequence A+B vs Treatment Sequence B+A: Geometric mean ratio: 0.96 (90% CI 0.90 to 1.02)
Treatment Sequence A+B vs Treatment Sequence B+A: Geometric mean ratio: 0.99 (90% CI 0.94 to 1.04)

Population analysed: Pharmacokinetic Analysis Set

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the start of randomization throughout the treatment period up to and including the Follow-up Visit. Serious adverse events were recorded from the time of informed consent.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Sequence A+B	0 of 35 (0%)	7 of 35 (20%)	0 of 35
Treatment Sequence B+A	0 of 36 (0%)	5 of 36 (13.9%)	0 of 36

Limitations and caveats (from the sponsor): The initial plan was to recruit 24 patients, but due to difficulties in determining the peak urinary uric acid excretion in 11 patients, it was decided to include 12 additional patients to ensure adequate sample size.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33075806Stack AG, Han D, Goldwater R, Johansson S, Dronamraju N, Oscarsson J, Johnsson E, Parkinson J, Erlandsson F. Dapagliflozin Added to Verinurad Plus Febuxostat Further Reduces Serum Uric Acid in Hyperuricemia: The QUARTZ Study. J Clin Endocrinol Metab. 2021 Apr 23;106(5):e2347-e2356. doi: 10.1210/clinem/dgaa748.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

2 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, Febuxostat and Dapagliflozin in people with Asymptomatic Hyperuricemia, run by AstraZeneca at 2 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 7 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 18 Jul 2019). 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?

Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7 (time frame: On Day -1 and Day 7 of each treatment period). The study lists 4 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 NCT03316131, which also lists 1 linked publication.

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 28 Aug 2019.