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

Primary Purpose

Chronic Kidney Disease, Hyperuricemia, Abnormal Renal Function

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Febuxostat
Benzbromarone
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Hyperuricemia, Renal Function, Chronic kidney disease, Febuxostat, Benzbromarone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Febuxostat

Benzbromarone

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

urine protein
adverse drug reaction

Full Information

First Posted
October 20, 2016
Last Updated
October 24, 2016
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02944214
Brief Title
Compare the Renal Protective Effects of Febuxostat and Benzbromarone in CKD Chinese Patients
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 Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hyperuricemia, Abnormal Renal Function
Keywords
Hyperuricemia, Renal Function, Chronic kidney disease, Febuxostat, Benzbromarone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Febuxostat
Arm Type
Experimental
Arm Description
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
Arm Title
Benzbromarone
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Other Intervention Name(s)
Uloric, Adenuric
Intervention Description
It acts as an inhibitor of xanthine oxidase, thus lowering urate concentrations in the body
Intervention Type
Drug
Intervention Name(s)
Benzbromarone
Other Intervention Name(s)
Desuric
Intervention Description
It is structurally related to the antiarrhythmic amiodarone, and it is a uricosuric agent and non-competitive inhibitor of xanthine oxidase
Primary Outcome Measure Information:
Title
serum creatinine, estimated glomerular filtration rate (eGFR)
Description
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.
Time Frame
up to 12th months
Secondary Outcome Measure Information:
Title
urine protein
Time Frame
6th months, 12th months
Title
adverse drug reaction
Time Frame
1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ai Peng, MD,PhD
Email
pengai@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ai Peng, MD, PhD
Organizational Affiliation
Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ai Peng, MD, PhD
Email
pengai@tongji.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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