Hemodialysis patients with hyperuricemia
Conditions
Interventions
Drug name: Feburic Tablets (generic name: febuxostat) Dose and dosing interval Oral dose of 10 mg (one 10 mg tablet or one half of a 20 mg tablet) after breakfast (preferably within 30 min)
Sponsors
Teikyo University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 20 years or older 2. Sex: Male or female 3. Patients with urine output <= 100 mL 4. Patients on stable maintenance hemodialysis who are admitted to the hospital for routine medical examination 5. Hyperuricemic patients with serum urate level > 7.0 mg/dL 6. Patients not receiving antihyperuricemics for at least 2 weeks 7. Patients who signed the informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: 1. Patients who present with gouty arthritis at the time of the examination before entry or at entry, or those in whom gouty arthritis had resolved only 2 weeks or sooner before entry 2. Patients who received drugs that must not be used within 2 weeks before entry 3. Patients complicated with any of the following diseases at entry: (i) Lesch-Nyhan syndrome [deficiency of hypoxanthine-phosphoribosyltransferase (HPRT)], (ii) elevated 5-phosphoribosyl-1-pyrophosphatase (PRPPase), (iii) congenital myogenic hyperuricemia, (iv) psoriasis vulgaris, (v) hemolytic anemia, (vi) hypothyroidism, (vii) rhabdomyolysis, (viii) glycogenosis I (due to lactic acidemia), (ix) toxemia of pregnancy, (x) polycystic kidney disease, (xi) lead nephropathy, (xii) Down syndrome, (xiii) sarcoidosis 4. Patients with liver damage (ALT >= 100 IU/L) 5. Patients with a history of hypersensitivity to febuxostat preparations 6. Patients who are or may be pregnant or breast-feeding 7. Patients receiving mercaptopurine hydrate or azathioprine 8. Other patients judged by the investigator to be ineligible for entry into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Pharmacokinetics (0-24 h) of febuxostat - Dialysis clearance of febuxostat - Efficacy of febuxostat in reducing serum urate levels - Tolerability (adverse events) of febuxostat | — |
Countries
Japan
Contacts
Public ContactSyunya Uchida
Teikyo University School of Medicine Department of Internal Medicine
Outcome results
None listed