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

NCT02944214 | Unknown

• 1 other identifier: FB2016MC
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Hyperuricemia; Abnormal Renal Function

Keywords

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

Outcome Measures

Primary Outcomes (1)

• serum creatinine, estimated glomerular filtration rate (eGFR)

  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.

  up to 12th months

Secondary Outcomes (2)

• urine protein

  6th months, 12th months

• adverse drug reaction

  1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months

Study Arms (2)

Febuxostat

EXPERIMENTAL

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

Drug: Febuxostat

Benzbromarone

EXPERIMENTAL

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

Drug: Benzbromarone

Interventions

Febuxostat DRUG

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

Also known as: Uloric, Adenuric

Febuxostat

Benzbromarone DRUG

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

Also known as: Desuric

Benzbromarone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperuricemia

Interventions

Febuxostat; Benzbromarone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ai Peng, MD, PhD

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

  STUDY CHAIR

Central Study Contacts

Ai Peng, MD,PhD

CONTACT

pengai@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 25, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 25, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)