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Compare the Renal Protective Effects of Febuxostat and Benzbromarone

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ClinicalTrials.gov Identifier: NCT02338323
Recruitment Status : Unknown
Verified May 2016 by Ai Peng, Shanghai 10th People's Hospital.
Recruitment status was:  Recruiting
First Posted : January 14, 2015
Last Update Posted : May 6, 2016
Sponsor:
Information provided by (Responsible Party):
Ai Peng, Shanghai 10th People's Hospital

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

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Hyperuricemia Abnormal Renal Function Drug: Febuxostat Drug: Benzbromarone Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Compare the Renal Protective Effects of Febuxostat and Benzbromarone in Chronic Kidney Disease Patients With GFR 20-50ml/Min
Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Febuxostat

Arm Intervention/treatment
Experimental: Febuxostat
take orally, 40mg per day, for 1 year
Drug: Febuxostat
It acts as an inhibitor of xanthine oxidase, thus lowering urate concentrations in the body
Other Names:
  • Uloric
  • Adenuric

Experimental: Benzbromarone
take orally, 50mg per day, for 1 year
Drug: Benzbromarone
It is structurally related to the antiarrhythmic amiodarone, and it is a uricosuric agent and non-competitive inhibitor of xanthine oxidase
Other Name: Desuric




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338323


Contacts
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Contact: Ai Peng, MD, PhD pengai@tongji.edu.cn

Locations
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China, Shanghai
Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: Ai Peng, MD, PhD       pengai@tongji.edu.cn   
Contact: Ling Wang, MD, PhD       nowax@126.com   
Sub-Investigator: Ling Wang, MD, PhD         
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
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Study Chair: Ling Wang, MD, PhD Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

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Responsible Party: Ai Peng, Chief of department of Nephrology & Rheumatology, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT02338323     History of Changes
Other Study ID Numbers: FB2015
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: May 6, 2016
Last Verified: May 2016

Keywords provided by Ai Peng, Shanghai 10th People's Hospital:
Hyperuricemia
Renal Function
Chronic kidney disease
Febuxostat
Benzbromarone

Additional relevant MeSH terms:
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Febuxostat
Kidney Diseases
Renal Insufficiency, Chronic
Hyperuricemia
Urologic Diseases
Renal Insufficiency
Pathologic Processes
Benzbromarone
Gout Suppressants
Antirheumatic Agents
Uricosuric Agents
Renal Agents