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

NCT ID: NCT02944214

Last Updated: 2016-10-25

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease Hyperuricemia Abnormal Renal Function

Keywords

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Hyperuricemia Renal Function Chronic kidney disease Febuxostat Benzbromarone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Febuxostat

take orally,10-80mg per day, for 1 year,start with a low dose, and adjust the dose according to the level of uric acid

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,12.5-100mg per day, for 1 year,start with a low dose, and adjust the dose according to the level of uric acid

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,20-60ml/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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ai Peng, 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

Central Contacts

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Ai Peng, MD,PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Ai Peng, MD, PhD

Role: primary

Other Identifiers

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FB2016MC

Identifier Type: -

Identifier Source: org_study_id