Comparing Dotinurad and Febuxostat for High Uric Acid and High Blood Pressure
Effect of Dotinurad in Hyperuricemia With Hypertension: a Randomized Study With Febuxostat (DIANA-NEXT)
This study is testing whether dotinurad can help lower blood pressure and improve artery health better than febuxostat in people with high uric acid and high blood pressure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Saga University Academic / other |
| Locations | 1 site (Saga, Saga-ken) |
| Trial ID | NCT06834230 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of dotinurad on the cardio-ankle vascular index (CAVI) in patients suffering from hyperuricemia and hypertension, comparing it to febuxostat. Eligible participants will be randomized into two groups, receiving either dotinurad or febuxostat, with a baseline examination followed by a 24-week observation period. The study aims to assess the impact of these medications on arterial stiffness without altering other treatments during the observation phase.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 and older with hyperuricemia and hypertension who have not received urate-lowering drugs recently.
Not a fit: Patients with unresolved gout, urinary tract stones, or secondary hyperuricemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with high uric acid levels and hypertension.
How similar studies have performed: Previous studies have shown promise in using similar approaches for managing hyperuricemia and hypertension, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Saga, Saga-ken
- Saga University — Saga, Saga-ken, Japan (Recruiting)
Study contacts
- Principal investigator: Koichi Node, Pr.,Dr. — Saga University
- Study coordinator: Koichi Koichi, Pr.,Dr.
- Email: next-diana@clin-med.org
- Phone: +81-952-28-8100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.