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

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ClinicalTrials.gov Identifier: NCT02944214
Recruitment Status : Not yet recruiting
First Posted : October 25, 2016
Last Update Posted : October 25, 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 in chinese, 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) 20-60 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compare the Renal Protective Effects of Febuxostat and Benzbromarone in Middle-to-late Stages of Chronic Kidney Disease Patients: a Multi-center Randomized Controlled Study
Study Start Date : October 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Febuxostat

Arm Intervention/treatment
Experimental: 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
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,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
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. serum creatinine, estimated glomerular filtration rate (eGFR) [ Time Frame: up to 12th months ]
    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.


Secondary Outcome Measures :
  1. urine protein [ Time Frame: 6th months, 12th months ]
  2. adverse drug reaction [ Time Frame: 1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 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,20-60ml/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

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): NCT02944214


Contacts
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Contact: Ai Peng, MD,PhD pengai@hotmail.com

Locations
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China, Shanghai
Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital Not yet recruiting
Shanghai, Shanghai, China, 200072
Contact: Ai Peng, MD, PhD       pengai@tongji.edu.cn   
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
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Study Chair: Ai Peng, MD, PhD Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

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Responsible Party: Ai Peng, Professor, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT02944214     History of Changes
Other Study ID Numbers: FB2016MC
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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