rate lowering drugs RandomIzed parallel-group Comparison study in the Chronic Kidney Disease patients with hypertension and hyperuricemia

Not Applicable

• Conditions: Chronic kidney disease with hyperuricemia and hypertension; hyperuricemia, hypertension, chronic kidney disease; Hyperuricemia/D033461

• Registration Number: JPRN-jRCTs071180033
• Lead Sponsor: Kohagura Kentaro

Brief Summary

Patients with stage 3 chronic kidney disease complicated with hypertension and hyperuricemia were enrolled and initiated treatment with benzbromarone or febuxostat. There were no significant differences in the rate of change in eGFR between the groups by week 52 after initiation of treatment. Febuxostat significantly reduced xanthine oxidase activity compared to benzbromarone. There were no significant differences between the groups in the other secondary endpoints of blood pressure, albuminuria, inflammati

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-07
• Study Completion: 2020-02-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1) Serum uric acid >7.0 mg/dL
2) Patients with hypertension defined as blood pressure measurements of equal or more than 140 mm Hg systolic and/or equal or more than 90 mm Hg diastolic or treatment with antihypertensive agents. No changes in prescription of antihypertensive agent 8 weeks before initiating the study drug.
3) CKD stage 3a and 3b
4) Age equal to or more than 20 years at obtaining informed consent
5) Outpatient
6) No history of gout
7) Obtained written informed consent from the patient for participation to the study

Exclusion Criteria

1) History of hypersensitivity to febuxostat or benzbromarone
2) AST or ALT is more than twice the upper limit of institutional normal range
3) eGFR <30ml/min/1.73m2 or dialysis patients.
4) Under treatment with thiazide diuretics or loop diuretics
5) History of treatment with urate lowering drugs within 2 weeks before determination of eligibility
6) History of coronary heart disease within 3 month before determination of eligibility
7) Patients with neoplasm, History of neoplasm except for the cured patients without recurrence within 5 years before determination of eligibility
8) Under treatment with the following: mercaptopurine,azathioprine, pyrazinamide, ethanbutol
9) Under treatment with warfarin
10) Women who are or may be pregnant, or brest-feeding
11) Participants of other clinical trials within 6 month before determination of eligibility
12) Urolithiasis
13) A patient who are judged inadequate for enrollment by an attending physician
14) A patient whose serum uric acid level is equal to or less than 7 mg/dl at Visit2 after randomization
15) A patient has been suffered from any of following: acute myocardial infarction, acute coronary syndrome, patients undergoing percutaneous coronary intervention or coronary artery bypass grafting, vetricular tachycarida, mutifocal ventricular arrhythmia and acute heart failure within three months before the eligibility assessment. This exclusion criteria was added since recent study suggested febuxostat may be associated with increased cardiovascular mortality compared with allopurinol among gout patients with major cardiovascular disease (N Engl J Med 2018;378:1200-10)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of change in estimated GFR from baseline to 52 weeks