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Completed

NCT Number: NCT02338323

Compare the Renal Protective Effects of Febuxostat and Benzbromarone

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

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, Shanghai Municipality, 200072, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Gout
  • Hyperuricemia patients without gout but have cardiovascular risk and serum uric acid > 480umol/L
  • Hyperuricemia patients without gout but with serum uric acid > 540umol/L

Exclusion criteria

  • GFR<20ml/min or GFR >50ml/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

Treatment and study plan

Febuxostat

Drug

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

Other names: Uloric, Adenuric

Benzbromarone

Drug

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

Other names: Desuric

Primary outcomes

  1. Renal function

    Time frame: up to 12th months

    Blood test for serum uric acid and creatinine, according to equation to estimate glomerular filtration rate

Secondary outcomes

  1. urine protein

    Time frame: 3rd months, 6th months, 9th months, 12th months

    urine test for microprotein markers and 24-hour urine protein quantitation

  2. adverse drug reaction

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

    record all the adverse drug reactions

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

Compare the Renal Protective Effects of Febuxostat and Benzbromarone in Chronic Kidney Disease Patients With GFR 20-50ml/Min

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 14, 2015
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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