Effect of Dotinurad in Hyperuricemia with Hypertension

Phase 4

Recruiting

• Conditions: Hyperuricemia or Gout; Hypertension
• Interventions: Drug: Dotinurad; Drug: Febuxostat

• Registration Number: NCT06834230
• Lead Sponsor: Saga University

Brief 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.

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 Timeline

• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-02-18
• Study First Posted: 2025-02-19
• Status Verified: 2025-03
• Study Start: 2025-03-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Primary Completion: 2027-07-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dotinurad	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).
Febuxostat	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).

Primary Outcome Measures

Name	Time	Method
Change in CAVI	24 weeks	Change in CAVI at 24 weeks after study drug administration

Secondary Outcome Measures

Name	Time	Method
Change in CAVI category	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
Change in CAVI	12 weeks	Change in CAVI at 12 weeks after study drug administration

Trial Locations

Locations (1)

Saga University Hospital; 🇯🇵 Saga, Japan