Effect of dotinurad in hyperuricemia with hypertension (DIANA)

Phase 4

• Conditions: hyperuricemia complicated by hypertension

• Registration Number: JPRN-jRCTs021210013
• Lead Sponsor: ode Koichi

Brief Summary

This study (the DIANA study) is a physician-initiated, multicenter, prospective, non-randomized, single-arm, open-label clinical trial to evaluate the effects of 24 weeks of dotinurad treatment on clinical measures, primarily serum uric acid levels, in hyperuricemic patients with treated hypertension. In the DIANA study, a total of 50 eligible patients were treated with dotinurad for 24 weeks and showed a significant reduction in the primary endpoint, a percent change in serum uric acid -35.8% (95% CI -39.7

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-24
• Study Completion: 2022-08-25
• Results First Posted: 2023-07-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1) Patients aged 20 years or older at the time when consent was obtained (regardless of gender)
2) Patients with hyperuricemia and a serum uric acid level of greater than 7.0 mg/dL
3) Patients with hypertension, who meet the definition of JSH2019, without change in the pharmacological and/or non-pharmacological treatment for hypertension within 4 weeks prior to eligibility assessment
4) Patients who provided their written consent to participate in this research

Exclusion Criteria

1) Patients whose inflammation did not subside after acute gouty arthritis
2) Patients who are currently suffering from urolithiasis
3) Patients with known secondary hyperuricemia who are suffering from any of the following diseases:
Lesch-Nyhan syndrome, phosphoribosyl pyrophosphate synthetase superactivity, congenital myogenic hyperuricemia, hematopoietic organ tumor (acute leukemia, malignant lymphoma, myeloproliferative disorder, myelodysplastic syndrome), solid tumor (breast cancer, seminoma, sarcoma, Wilms tumor, small cell lung cancer), non-neoplastic disease (psoriasis vulgaris, secondary polycythemia, hemolytic anemia), tumor lysis syndrome, rhabdomyolysis, hypothyroidism, polycystic kidney, lead poisoning/lead nephropathy, Down's syndrome, familial juvenile gouty nephropathy, hyperlactacidemia, or glycogen storage disease type I
4) Patients with hypertensive emergency and urgency
5) Patients with complications from active malignancy
6) Patients with serious hepatic dysfunction
7) Patients with severe renal dysfunction with oliguria or anuria
8) Patients who are pregnant, suspected to be pregnant, or breastfeeding
9) Patients with a history of hypersensitivity to the ingredients contained in dotinurad preparations
10) Patients who the principal investigator or subinvestigator considers not suitable for this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified