Effect of Dotinurad in Hyperuricemia With Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dotinurad, Febuxostat.
- Who it may be relevant to
- Registry conditions: Hyperuricemia or Gout, Hypertension. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Dotinurad in Hyperuricemia With Hypertension: a Randomized Study With Febuxostat (DIANA-NEXT)
Overview
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.
Interventions
- 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). - 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).
Primary outcome measures
- Change in CAVI [Time frame: 24 weeks]
Secondary outcome measures (3)
- Change in CAVI category [Time frame: 24 weeks]
- Change in CAVI [Time frame: 12 weeks]
- Change in CAVI category [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Saga University — Saga
Identifiers
NCT: NCT06834230 · 00003