Chronic Kidney DiseaseNCT02944214
Compare the Renal Protective Effects of Febuxostat and Benzbromarone in CKD Chinese Patients
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 in chinese, and which one could be better. Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 800 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Dec 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic kidney disease patients with glomerular filtration rate (GFR,20-60ml/min) who match one of the following criteria:
- Gout
- serum uric acid > 480umol/L
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ai Peng, MD,PhD contact
China1 site
Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Ai Peng, MD, PhD, pengai@tongji.edu.cn
About this study
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
The purpose of this study is to determine whether febuxostat and benzbromarone could protect renal function in chinese, and which one could be better.
Read the 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.
- 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,10-80mg per day, for 1 year,start with a low dose, and adjust the dose according to the level of uric acid Receives: Drug: Febuxostat |
| Benzbromarone | Experimental | 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 Receives: Drug: Benzbromarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12th months
Secondary outcomes (2)
urine protein
Measured: 6th months, 12th months
adverse drug reaction
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 posted25 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
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
- None (open label)
- Enrolment
- 800 participants (estimated)
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
- Ai Peng, MD, PhD, Study chair, Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944214
- Sponsor's protocol ID
- FB2016MC
- Status last verified
- Oct 2016
- First submitted
- 20 Oct 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. 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 Middle-to-late Stages of Chronic Kidney Disease Patients: a Multi-center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02944214
- Acronym / sponsor ID
- FB2016MC
- Keywords
- Hyperuricemia, Renal Function, Chronic kidney disease, Febuxostat, Benzbromarone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 25 Oct 2016 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Febuxostat | Experimental | Drug: Febuxostattake orally,10-80mg per day, for 1 year,start with a low dose, and adjust the dose according to the level of uric acid |
| Benzbromarone | Experimental | Drug: Benzbromaronetake 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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
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.
2 secondary outcomes
urine protein
Time frame: 6th months, 12th months
adverse drug reaction
Time frame: 1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Ai Peng, MD,PhD contact
Ai Peng, 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 3 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: status not confirmed, as of the sponsor's last update on 25 Oct 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ai Peng, MD,PhD (pengai@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum creatinine, estimated glomerular filtration rate (eGFR) (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 25 Oct 2016.