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Comparison of anti-proteinuric effects of febuxostat and conventional therapies for hyperuricemia in patients with chronic kidney disease: an open-label randomized controlled trial

Comparison of anti-proteinuric effects of febuxostat and conventional therapies for hyperuricemia in patients with chronic kidney disease: an open-label randomized controlled trial - Reno-protective Effect of Febuxostat in Renal-dysfunctional Secondary Hyperuricemia (Tohoku REFRESH study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009942
Enrollment
70
Registered
2013-02-15
Start date
2013-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperuricemia, chronic kidney disease

Interventions

Febuxostat 10-60 mg/day to target serum urate range from 4 to 6 mg/dL from the baseline to 48 weeks Conventional treatments (allopurinol and/or benzbromarone, or no drug) to target serum urate range f

Sponsors

Division of Nephrology, Endocrinology, and Vascular Medicine, Tohoku University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Obtained written informed consent from the patient for the study participation 2) Stable condition for more than 3 months on the treatments by a nephrologist 3) Age >-20 and <80 years old 4) eGFR >-15 and <45 mL/min/1.73m2 5) Serum uric acid >-7.0 mg/dL and <11.0 mg/dL 6) Urinary protein creatinine ratio >-0.3 and <3.5 g/gCr 7) Outpatient who can visit bimonthly at least

Exclusion criteria

Exclusion criteria: 1) High-risk patients requiring dialysis or renal transplantation within 48 weeks 2) History of gout 3) Patients with Cancer or liver disease (HBV/HCV hepatitis, cirrhosis, and the other liver injuries showing AST/ALT values more than twice as high of normal values 4) HbA1c (JDS) >-7.0% with 2 months prior to the entry 5) Office systolic blood pressure >-160 mmHg or diastolic blood pressure >-100 mmHg both at recent twice office visits before the entry 6) Severe heart failure or edema 7) History of renal replacement therapy 8) History of febuxostat intake within four weeks before the entry 9) History of hypersensitivity to allopurinol, benzbromarone, or febuxostat 10) Judged as ineligible in the opinion of the attending physician 11) Pregnancy or nursing

Design outcomes

Primary

MeasureTime frame
Urinary protein creatinine ratio at 24 weeks after treatments

Secondary

MeasureTime frame
Chronological changes of urinary protein excretion from the baseline to 24 weeks and those from 24 to 48 weeks. Estimated GFR, plasma renin activity, plasma aldosterone concentration, urinary albumin creatinine ratio, urinary L-FABP, urinary 8-OHdG, serum methylglyoxal, and blood pressure

Countries

Japan

Contacts

Public ContactTakashi Nakamichi

Tohoku University Graduate School of Medicine Division of Nephrology, Endocrinology, and Vascular Medicine

tnakamichi@med.tohokou.ac.jp022-717-7163

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026