Effect of dotinurad in hyperuricemia with hypertension: a randomized study with febuxostat (DIANA-NEXT)

Recruiting

• Conditions: Hyperuricemia complicated by hypertension

• Registration Number: jRCTs021240066

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-24
• Study Start: 2025-03-28
• Last Update Posted: 2025-05-21

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, 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 or subinvestigator.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
change in CAVI category in the vascular insufficiency index at 24 weeks	24 weeks after treatment with study drug	CAVI category (<8.0: normal, 8.0 to 9.0: borderline, 9.0 or greater: abnormal)
Change in CAVI category in the vascular insufficiency index at 12 weeks	12 weeks after treatment with study drug	CAVI category (<8.0: normal, 8.0 to 9.0: borderline, 9.0 or greater: abnormal)