hyperuricemia
Conditions
Interventions
For patients with serum uric acid levels>
6.0mg/dl,dotinurad 0.5mg/day will be added,or the dotinurad dosage will be adjusted so that serum uric acid levels are 2-6mg/dl and serum uric acid fluctuations are within 0.5mg/dl with follow-up ever
s wishes,personality,compliance,etc.For uric acid levels <
2.0mg/dl,dotinurad will be reduced or discontinued. (i)New dotinurad administration group:For patients with hyperuricemia (>
6.0mg/dl),dotinurad 0.5mg/day will be started after obtaining consent. Increase dotinurad to keep serum uric acid levels within 2-6mg at follow-up every 4(+/-2) weeks
(ii) Dotinurad addition group t
Dotinurad 0.5mg 1mg Febuxostat 10mg 20mg 40mg
Dotinurad 0.5mg 1mg 2mg Topiroxostat 20mg 40mg 60mg:Dotinurad 0.5mg 1mg 2mg Benzbromarone 50mg=Converted in Dotinurad 2mg, Probenecid 1000mg=Converted in dotinurad 2mg, Bucolom 600mg=Converted in doti
Sponsors
Tokushukai Medical Corporation Shonan Kamakura General Hospital (Clinical Research Center)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with hyperuricaemia (>6.0 mg/dl) 2) Patients without renal urinary tract stones on computed tomography (CT) 3) Patients aged 20 years or older (regardless of gender) at the time of consent 4) Patients who have been fully informed about their participation in this study and have given their free written consent to participate in the study after having been fully informed of the study 5) Patients who are attending an outpatient clinic at the time of consent
Exclusion criteria
Exclusion criteria: 1) Patients with hypouricemia (<2.0 mg/dl) 2) Patients with a history of urinary tract stones or the presence of renal UTI stones evident on imaging 3) Patients who have taken Dotinurado. within 26 weeks prior to obtaining consent 4) Women who are pregnant or may become pregnant 5) Women who are breastfeeding 6) Patients who received other study drugs or investigational drugs within 3 months before starting study drug administration 7) Patients with a history of hypersensitivity to any component of the study drug 8) Other patients deemed unsuitable as study subjects by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of decline of eGFR at the start of treatment and every 24 weeks Changes in serum uric acid level and Cre(eGFR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective symptoms and objective findings Hematological tests: white blood cells, red blood cells, hemoglobin, hematocrit, platelets Blood biochemistry tests: BUN, creatinine, UA, AST, ALT, LDH, albumin, electrolytes (Na, K, Cl), indoxyl sulfate, ALP, iPTH, Ca, Mg, IP, T-Cho, TG, HDL-C, LDL-C, CRP, FGF23, erythropoietin concentration, HCO3 Urine tests: urine qualitative (protein, sugar, urobilinogen, occult blood, ketones, pH, specific gravity), urine sediment, urinary Cr, urinary UA, be-ta2MG, NAG, NGAL Abdominal CT scan: Ultrasound tests: carotid artery IMT, cardiac echo, renal echo (RI, SWE) Physiological tests: FMD, SPP, CAVI | — |
Countries
Japan
Contacts
Public Contactkyoko maesato
shonan kamakura general hospital kidney disease and transplant center
Outcome results
None listed