Compare the Renal Protective Effects of Febuxostat and Benzbromarone

NCT ID: NCT02338323

Last Updated: 2019-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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Chronic kidney disease patients with hyperuricemia and glomerular filtration rate (GFR) 20-50 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.

Conditions

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Chronic Kidney Disease Hyperuricemia Abnormal Renal Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Febuxostat

take orally, 40mg per day, for 1 year

Group Type EXPERIMENTAL

Febuxostat

Intervention Type DRUG

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

Benzbromarone

take orally, 50mg per day, for 1 year

Group Type EXPERIMENTAL

Benzbromarone

Intervention Type DRUG

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

Interventions

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Febuxostat

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

Intervention Type DRUG

Benzbromarone

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

Intervention Type DRUG

Other Intervention Names

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Uloric Adenuric Desuric

Eligibility Criteria

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Inclusion Criteria

Chronic kidney disease patients with glomerular filtration rate (GFR,20-50ml/min) who match one of the following criteria:

1. Gout
2. Hyperuricemia patients without gout but have cardiovascular risk and serum uric acid \> 480umol/L
3. Hyperuricemia patients without gout but with serum uric acid \> 540umol/L

Exclusion Criteria

1. GFR\<20ml/min or GFR \>50ml/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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ai Peng

Chief of department of Nephrology & Rheumatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ling Wang, MD, PhD

Role: STUDY_CHAIR

Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

Locations

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Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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FB2015

Identifier Type: -

Identifier Source: org_study_id

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