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

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

Node Koichi

Saga University Hospital

1-1, 5-chome, Nabeshima, Saga-shi, Saga

node@cc.saga-u.ac.jp

Tanaka Atsushi

Saga University Hospital

1-1, 5-chome, Nabeshima, Saga-shi, Saga

+81-952-34-2364

tanakaa2@cc.saga-u.ac.jp

Recruiting

Mar. 24, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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

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.

Both

Hyperuricemia complicated by hypertension

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. However, patients who are using uric acid-lowering drugs at the time of obtaining consent will be withdrawn for at least 27 days before the start of study drug administration, after which eligibility will be determined and all patients who meet the eligibility criteria will be enrolled. In principle, a baseline (0-week) examination will be conducted within 70 days 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.

Changes in CAVI at 24 weeks after study drug administration

1. change in CAVI category (<8.0: normal, 8.0 to 9.0: borderline, 9.0 or greater: abnormal) in the vascular insufficiency index at 24 weeks after treatment with study drug (key secondary endpoints)
Change in CAVI at 12 weeks after treatment with study drug
Change in CAVI category in the vascular insufficiency index (<8.0: normal, 8.0 to 9.0: borderline, 9.0 or greater: abnormal) at 12 weeks after treatment with study drug

+81-24-547-1825

Jan. 30, 2025

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