Effect of Dotinurad in Hyperuricemia With Hypertension (DIANA-NEXT)

December 7, 2025 updated by: Koichi Node, Saga University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
    • Saga-ken
      • Saga, Saga-ken, Japan, 840-8502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged 20 years or older at the time of consent (regardless of gender)
  2. 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
  3. 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
  4. Patients who have given written consent to participate in this study

Exclusion Criteria:

  1. Patients with unsettled gout after acute gouty arthritis
  2. Patients currently suffering from urinary tract stones
  3. 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
  4. Patients with hypertensive emergencies and urgency
  5. Patients with active malignancies
  6. Patients with severe hepatic dysfunction
  7. Patients with severe renal dysfunction with oliguria or anuria
  8. Pregnant, possibly pregnant, or lactating patients
  9. Patients with a history of hypersensitivity to the components of dotinurad and febuxostat
  10. Patients receiving mercaptopurine hydrate or azathioprine
  11. Other patients deemed inappropriate for this study by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dotinurad
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).
Drug: Dotinurad
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).
Other Names:
  • URECE
Active Comparator: Febuxostat
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).
Drug: Febuxostat
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).
Other Names:
  • Feburic

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in CAVI
Time Frame: 24 weeks
Change in CAVI at 24 weeks after study drug administration
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in CAVI category
Time Frame: 24 weeks
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)
24 weeks
Change in CAVI
Time Frame: 12 weeks
Change in CAVI at 12 weeks after study drug administration
12 weeks
Change in CAVI category
Time Frame: 12 weeks
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
12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in serum uric acid levels
Time Frame: 4, 8, 12 and 24 weeks
Changes in serum uric acid levels at 4, 8, 12 and 24 weeks after study drug administration
4, 8, 12 and 24 weeks
Percentage of patients whose serum uric acid levels reach 6.0 mg/dL or less
Time Frame: 4, 8, 12 and 24 weeks
Percentage of patients whose serum uric acid levels reach 6.0 mg/dL or less at 4, 8, 12, and 24 weeks after study drug administration
4, 8, 12 and 24 weeks
Change in AI
Time Frame: 24 weeks
Change in AI at 24 weeks after study drug administration
24 weeks
Change in %MAP
Time Frame: 24 weeks
Change in %MAP at 24 weeks after study drug administration
24 weeks
Change in serum NT-proBNP
Time Frame: 24 weeks
Change in serum NT-proBNP at 24 weeks after study drug administration
24 weeks
Change in serum CRP
Time Frame: 24 weeks
Change in serum CRP at 24 weeks after study drug administration
24 weeks
Change in serum oxidized LDL
Time Frame: 24 weeks
Change in serum oxidized LDL at 24 weeks after study drug administration
24 weeks
Change in urinary albumin-creatinine ratio
Time Frame: 24 weeks
Change in urinary albumin-creatinine ratio at 24 weeks after study drug administration
24 weeks
Change in urinary 8-OHdG
Time Frame: 24 weeks
Change in urinary 8-OHdG at 24 weeks after study drug administration
24 weeks
Change in urinary NAG
Time Frame: 24 weeks
Change in urinary NAG at 24 weeks after study drug administration
24 weeks
Changes in systolic and diastolic blood pressures
Time Frame: 12 and 24 weeks
Changes in systolic and diastolic blood pressures at 12 and 24 weeks after study drug administration
12 and 24 weeks
Changes in pulse pressure (systolic blood pressure minus diastolic blood pressure)
Time Frame: 12 and 24 weeks
Changes in pulse pressure (systolic blood pressure minus diastolic blood pressure) at 12 and 24 weeks after study drug administration
12 and 24 weeks
Changes in AST
Time Frame: 12 and 24 weeks
Changes in AST at 12 and 24 weeks after study drug administration
12 and 24 weeks
Changes in ALT
Time Frame: 12 and 24 weeks
Changes in ALT at 12 and 24 weeks after study drug administration
12 and 24 weeks
Changes inγ-GTP
Time Frame: 12 and 24 weeks
Changes inγ-GTP at 12 and 24 weeks after study drug administration
12 and 24 weeks
Changes in HDL-C
Time Frame: 12 and 24 weeks
Changes in HDL-C at 12 and 24 weeks after study drug administration
12 and 24 weeks
Changes in LDL-C
Time Frame: 12 and 24 weeks
Changes in LDL-C at 12 and 24 weeks after study drug administration
12 and 24 weeks
Changes in TG
Time Frame: 12 and 24 weeks
Changes in TG at 12 and 24 weeks after study drug administration
12 and 24 weeks
Changes in WBC (including fractions)
Time Frame: 12 and 24 weeks
Changes in WBC (including fractions) at 12 and 24 weeks after study drug administration
12 and 24 weeks
Changes in PLT
Time Frame: 12 and 24 weeks
Changes in PLT at 12 and 24 weeks after study drug administration
12 and 24 weeks
Changes in Cr
Time Frame: 12 and 24 weeks
Changes in Cr at 12 and 24 weeks after study drug administration
12 and 24 weeks
Changes in eGFR
Time Frame: 12 and 24 weeks
Changes in eGFR at 12 and 24 weeks after study drug administration
12 and 24 weeks
Changes in FIB-4 index
Time Frame: 12 and 24 weeks
Changes FIB-4 index at 12 and 24 weeks after study drug administration
12 and 24 weeks
Change in echocardiographic parameters (LVEDV)
Time Frame: 24 weeks
Change in LVEDV at 24 weeks after study drug administration
24 weeks
Changes in echocardiographic parameters (LVESV)
Time Frame: 24 weeks
Changes in LVESV at 24 weeks after study drug administration
24 weeks
Change in echocardiographic parameters (LVEF)
Time Frame: 24 weeks
Change in LVEF at 24 weeks after study drug administration
24 weeks
Change in echocardiographic parameters (septal e')
Time Frame: 24 weeks
Change in septal e' at 24 weeks after study drug administration
24 weeks
Change in echocardiographic parameters (lateral e')
Time Frame: 24 weeks
Change in lateral e' at 24 weeks after study drug administration
24 weeks
Change in echocardiographic parameters (mitral annular velocity (E))
Time Frame: 24 weeks
Change in mitral annular velocity (E) at 24 weeks after study drug administration
24 weeks
Change in echocardiographic parameters (E/e')
Time Frame: 24 weeks
Change in E/e' at 24 weeks after study drug administration
24 weeks
Change in echocardiographic parameters (LVMI)
Time Frame: 24 weeks
Change in LVMI at 24 weeks after study drug administration
24 weeks
Change in echocardiographic parameters (LAVI)
Time Frame: 24 weeks
Change in LAVI at 24 weeks after study drug administration
24 weeks
Adverse events
Time Frame: 24 weeks
Adverse events that occurred after study drug administration
24 weeks
Changes in protein levels as determined by proteomics analysis
Time Frame: 24 weeks
Changes in protein levels as determined by proteomics analysis(Olink Target 96 Inflammation analysis, Olink Target 96 CVDⅡ analysis, Olink Target 96 CVDⅢ analysis) at 24 weeks after study drug administration
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saga University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Koichi Node, Pr.,Dr., Saga University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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