Compare the Renal Protective Effects of Febuxostat and Benzbromarone in CKD Chinese Patients

Compare the Renal Protective Effects of Febuxostat and Benzbromarone in Middle-to-late Stages of Chronic Kidney Disease Patients: a Multi-center Randomized Controlled Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02944214

Enrollment

800

Registered

2016-10-25

Start date

2016-10-31

Completion date

2019-12-31

Last updated

2016-10-25

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

Conditions

Abnormal Renal Function, Chronic Kidney Disease, Hyperuricemia

Keywords

Hyperuricemia, Renal Function, Chronic kidney disease, Febuxostat, Benzbromarone

Brief summary

The purpose of this study is to determine whether febuxostat and benzbromarone could protect renal function in chinese, and which one could be better.

Detailed description

Chronic kidney disease patients with hyperuricemia and glomerular filtration rate (GFR) 20-60 ml/min were treated by febuxostat or benzbromarone. Follow up the changes of serum uric acid, serum creatinine and GFR levels. Compare the effects on renal function of these two drugs.

Interventions

DRUGFebuxostat

It acts as an inhibitor of xanthine oxidase, thus lowering urate concentrations in the body

DRUGBenzbromarone

It is structurally related to the antiarrhythmic amiodarone, and it is a uricosuric agent and non-competitive inhibitor of xanthine oxidase

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Chronic kidney disease patients with glomerular filtration rate (GFR,20-60ml/min) who match one of the following criteria: 1. Gout 2. serum uric acid \> 480umol/L

Exclusion criteria

1. GFR\<20ml/min or GFR \>60ml/min 2. Liver dysfunction (Aspartate transaminase or/and alanine aminotransferase exceed 2 times of normal range) 3. Urinary tract obstruction 4. unstable angina, heart failure (stage III-IV, NYHA), new stroke, need diuretics for long-term treatment 5. Severe lung diseases or cancers 6. Pregnant woman or woman who prepare to be pregnant，nursing mothers 7. unable to sign informed consent form，or disagree with following-up

Design outcomes

Primary

Measure	Time frame	Description
serum creatinine, estimated glomerular filtration rate (eGFR)	up to 12th months	eGFR will be estimated by CKD-EPI equation, which is most widely used recently in the world. eGFR will be calculated according to serum creatinine, age, gender and race.

Secondary

Measure	Time frame
adverse drug reaction	1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months
urine protein	6th months, 12th months

Countries

China

Contacts

Primary ContactAi Peng, MD,PhD

pengai@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026