Chronic Kidney DiseaseNCT02338323
Compare the Renal Protective Effects of Febuxostat and Benzbromarone
A study testing Febuxostat and Benzbromarone in people with Chronic Kidney Disease and Hyperuricemia, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether febuxostat and benzbromarone could protect renal function, and which one could be better. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease, Hyperuricemia, Abnormal Renal Function
- What is being tested?
- Febuxostat and Benzbromarone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: Compare the Renal Protective Effects of Febuxostat and Benzbromarone in Chronic Kidney Disease Patients With GFR 20-50ml/Min
The purpose of this study is to determine whether febuxostat and benzbromarone could protect renal function, and which one could be better.
Read the 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.
- Being tested
- Febuxostat, Benzbromarone
- Keywords
- Hyperuricemia, Renal Function, Chronic kidney disease, Febuxostat, Benzbromarone
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FebuxostatDrug
Also called Uloric, Adenuric
It acts as an inhibitor of xanthine oxidase, thus lowering urate concentrations in the body
BenzbromaroneDrug
Also called Desuric
It is structurally related to the antiarrhythmic amiodarone, and it is a uricosuric agent and non-competitive inhibitor of xanthine oxidase
| Study group | Role | What they receive |
|---|---|---|
| Febuxostat | Experimental | take orally, 40mg per day, for 1 year Receives: Drug: Febuxostat |
| Benzbromarone | Experimental | take orally, 50mg per day, for 1 year Receives: Drug: Benzbromarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
Blood test for serum uric acid and creatinine, according to equation to estimate glomerular filtration rate
Measured: up to 12th months
Secondary outcomes (2)
urine protein
urine test for microprotein markers and 24-hour urine protein quantitation
Measured: 3rd months, 6th months, 9th months, 12th months
adverse drug reaction
record all the adverse drug reactions
Measured: 1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ai Peng, Shanghai 10th People's Hospital
- Investigators
- Ling Wang, MD, PhD, Study chair, Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338323
- Sponsor's protocol ID
- FB2015
- Status last verified
- Jul 2019
- First submitted
- 10 Jan 2015
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Renal Protective Effects of Febuxostat and Benzbromarone in Chronic Kidney Disease Patients With GFR 20-50ml/Min
- ClinicalTrials.gov ID
- NCT02338323
- Acronym / sponsor ID
- FB2015
- Keywords
- Hyperuricemia, Renal Function, Chronic kidney disease, Febuxostat, Benzbromarone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether febuxostat and benzbromarone could protect renal function, and which one could be better.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Febuxostat | Experimental | Drug: Febuxostattake orally, 40mg per day, for 1 year |
| Benzbromarone | Experimental | Drug: Benzbromaronetake orally, 50mg per day, for 1 year |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FebuxostatAlso: Uloric, AdenuricIt acts as an inhibitor of xanthine oxidase, thus lowering urate concentrations in the body | Drug | Febuxostat |
| BenzbromaroneAlso: DesuricIt is structurally related to the antiarrhythmic amiodarone, and it is a uricosuric agent and non-competitive inhibitor of xanthine oxidase | Drug | Benzbromarone |
Primary outcome
Renal function
Time frame: up to 12th months
Blood test for serum uric acid and creatinine, according to equation to estimate glomerular filtration rate
2 secondary outcomes
urine protein
Time frame: 3rd months, 6th months, 9th months, 12th months
adverse drug reaction
Time frame: 1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling Wang, MD, PhD study chair
Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Febuxostat and Benzbromarone in people with Chronic Kidney Disease and Hyperuricemia, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function (time frame: up to 12th months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.