Hyperuricemia or GoutPhase 4DIANA-NEXTNCT06834230
Effect of Dotinurad in Hyperuricemia With Hypertension
A Phase 4 study testing Dotinurad and Febuxostat in people with Hyperuricemia or Gout and Hypertension, run by Saga University at 1 site in Japan.
Trial summary
The effect of dotinurad on CAVI (cardio-ankle vascular index) will be compared with that of febuxostat in patients with hyperuricemia complicated by hypertension. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperuricemia or Gout, Hypertension
- What is being tested?
- Dotinurad and Febuxostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteJapan
- Study dates
- 28 Mar 2025to 31 Mar 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 years or older at the time of consent (regardless of gender)
- Patients with hyperuricemia with serum uric acid level >7.0 mg/dL who have not received any urate lowering drug within 27 days prior to obtaining consent, or patients who were receiving urate lowering drugs at the time of obtaining consent but have been off the drugs for more than 27 days
- Hypertensive patients who meet the definition of hypertension in the latest Hypertension Treatment Guidelines of the Japanese Society of Hypertension and whose treatment for hypertension (with or without drug therapy) has not changed within 4 weeks prior to eligibility determination
- Patients who have given written consent to participate in this study
Who cannot join
- Patients with unsettled gout after acute gouty arthritis
- Patients currently suffering from urinary tract stones
- Patients with known secondary hyperuricemia who have Lesch-Nyhan syndrome, hyperphosphoribosyl pyrophosphate synthase, congenital myogenic hyperuricemia, hematopoietic tumors (acute leukemia, malignant lymphoma, myeloproliferative disorders, myelodysplastic syndrome), solid tumors (breast cancer, seminoma, sarcoma, Wilms' tumor, small cell lung cancer), non-neoplastic diseases (psoriasis vulgaris, secondary polycythemia vera, hemolytic anemia), tumor melting syndrome, rhabdomyolysis, hypothyroidism, polycystic kidney disease, lead poisoning/lead nephropathy, Down syndrome, familial juvenile gout nephropathy, hyperlactatemia, or type 1 glycogenic disease
- Patients with hypertensive emergencies and urgency
- Patients with active malignancies
- Patients with severe hepatic dysfunction
Show all 11Show fewer
- Patients with severe renal dysfunction with oliguria or anuria
- Pregnant, possibly pregnant, or lactating patients
- Patients with a history of hypersensitivity to the components of dotinurad and febuxostat
- Patients receiving mercaptopurine hydrate or azathioprine
- Other patients deemed inappropriate for this study by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Saga University
Saga, Saga-ken, 840-8502
Atsushi Tanaka, +81-952-34-2364, tanakaa2@cc.saga-u.ac.jp
About this study
Official title: Effect of Dotinurad in Hyperuricemia With Hypertension: a Randomized Study With Febuxostat (DIANA-NEXT)
The effect of dotinurad on CAVI (cardio-ankle vascular index) will be compared with that of febuxostat in patients with hyperuricemia complicated by hypertension.
Read the detailed description
After determining eligibility of patients for whom consent is obtained, all patients who meet the eligibility criteria will be enrolled and randomized to one of two groups: dotinurad or febuxostat. In principle, a baseline (0-week) examination will be conducted within 70days after obtaining consent, followed by 24 weeks of observation and examination. During the observation period, no changes or additions to the dosage or administration of drugs other than the study drug will be made in principle, but changes or additions will be permitted under the overall clinical judgment of the physician in charge according to the medical conditions of the study participants.
- Conditions
- Hyperuricemia or Gout, Hypertension
- Being tested
- Dotinurad, Febuxostat
- Keywords
- Febuxostat, Dotinurad, CAVI, Arterial stiffness
- Medical subject headings
- Hyperuricemia, Gout, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DotinuradDrug
Also called URECE
Start at 0.5 mg once daily, and then referring to the attached document, gradually increase the dose to the maintenance dose (2 mg once daily).
FebuxostatDrug
Also called Feburic
Start at 10 mg once daily, and then referring to the attached document, gradually increase the dose to the maintenance dose (40 mg once daily).
| Study group | Role | What they receive |
|---|---|---|
| Dotinurad | Experimental | Start at 0.5 mg once daily, and then referring to the attached document and the following dosage examples, gradually increase the dose to the maintenance dose (2 mg once daily). Receives: Drug: Dotinurad |
| Febuxostat | Active comparator | Start at 10 mg once daily, and then referring to the attached document and the following dosage examples, gradually increase the dose to the maintenance dose (40 mg once daily). Receives: Drug: Febuxostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CAVI
Change in CAVI at 24 weeks after study drug administration
Measured: 24 weeks
Secondary outcomes (3)
Change in CAVI category
Change in CAVI category (<8.0: normal, 8.0 to 9.0: borderline, 9.0 or greater: abnormal) at 24 weeks after study drug administration (key secondary endpoint)
Measured: 24 weeks
Change in CAVI
Change in CAVI at 12 weeks after study drug administration
Measured: 12 weeks
Change in CAVI category
Change in CAVI category (<8.0: normal, 8.0 to 9.0: borderline, 9.0 or greater: abnormal) at 12 weeks after study drug administration
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start28 Mar 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperuricemia or GoutStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saga University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koichi Node, Saga University
- Investigators
- Koichi Node, Pr.,Dr., Principal investigator, Saga University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834230
- Sponsor's protocol ID
- 00003
- Acronym
- DIANA-NEXT
- Status last verified
- Dec 2025
- First submitted
- 30 Jan 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dotinurad in Hyperuricemia With Hypertension: a Randomized Study With Febuxostat (DIANA-NEXT)
- ClinicalTrials.gov ID
- NCT06834230
- Acronym / sponsor ID
- DIANA-NEXT / 00003
- Conditions
- Hyperuricemia or Gout, Hypertension
- Keywords
- Febuxostat, Dotinurad, CAVI, Arterial stiffness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Saga UniversityUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of dotinurad on CAVI (cardio-ankle vascular index) will be compared with that of febuxostat in patients with hyperuricemia complicated by hypertension.
Detailed description
After determining eligibility of patients for whom consent is obtained, all patients who meet the eligibility criteria will be enrolled and randomized to one of two groups: dotinurad or febuxostat. In principle, a baseline (0-week) examination will be conducted within 70days after obtaining consent, followed by 24 weeks of observation and examination. During the observation period, no changes or additions to the dosage or administration of drugs other than the study drug will be made in principle, but changes or additions will be permitted under the overall clinical judgment of the physician in charge according to the medical conditions of the study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Dotinurad | Experimental | Drug: DotinuradStart at 0.5 mg once daily, and then referring to the attached document and the following dosage examples, gradually increase the dose to the maintenance dose (2 mg once daily). |
| Febuxostat | Active comparator | Drug: FebuxostatStart at 10 mg once daily, and then referring to the attached document and the following dosage examples, gradually increase the dose to the maintenance dose (40 mg once daily). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 20 years or older at the time of consent (regardless of gender)
- Patients with hyperuricemia with serum uric acid level >7.0 mg/dL who have not received any urate lowering drug within 27 days prior to obtaining consent, or patients who were receiving urate lowering drugs at the time of obtaining consent but have been off the drugs for more than 27 days
- Hypertensive patients who meet the definition of hypertension in the latest Hypertension Treatment Guidelines of the Japanese Society of Hypertension and whose treatment for hypertension (with or without drug therapy) has not changed within 4 weeks prior to eligibility determination
- Patients who have given written consent to participate in this study
Key exclusion criteria (11 listed)
- Patients with unsettled gout after acute gouty arthritis
- Patients currently suffering from urinary tract stones
- Patients with known secondary hyperuricemia who have Lesch-Nyhan syndrome, hyperphosphoribosyl pyrophosphate synthase, congenital myogenic hyperuricemia, hematopoietic tumors (acute leukemia, malignant lymphoma, myeloproliferative disorders, myelodysplastic syndrome), solid tumors (breast cancer, seminoma, sarcoma, Wilms' tumor, small cell lung cancer), non-neoplastic diseases (psoriasis vulgaris, secondary polycythemia vera, hemolytic anemia), tumor melting syndrome, rhabdomyolysis, hypothyroidism, polycystic kidney disease, lead poisoning/lead nephropathy, Down syndrome, familial juvenile gout nephropathy, hyperlactatemia, or type 1 glycogenic disease
- Patients with hypertensive emergencies and urgency
- Patients with active malignancies
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 |
|---|---|---|
| DotinuradAlso: URECEStart at 0.5 mg once daily, and then referring to the attached document, gradually increase the dose to the maintenance dose (2 mg once daily). | Drug | Dotinurad |
| FebuxostatAlso: FeburicStart at 10 mg once daily, and then referring to the attached document, gradually increase the dose to the maintenance dose (40 mg once daily). | Drug | Febuxostat |
Primary outcome
Change in CAVI
Time frame: 24 weeks
Change in CAVI at 24 weeks after study drug administration
3 secondary outcomes
Change in CAVI category
Time frame: 24 weeks
Change in CAVI
Time frame: 12 weeks
Change in CAVI category
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Koichi Node, Pr.,Dr. principal investigator
Saga University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dotinurad and Febuxostat in people with Hyperuricemia or Gout and Hypertension, run by Saga University at 1 site in Japan.
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 11 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: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Koichi Koichi, Pr.,Dr. (+81-952-28-8100, next-diana@clin-med.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CAVI (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2025.