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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014787
Receipt No. R000017192
Scientific Title Effect of Febuxostat on Flow Mediated Diameter in hyperuricemia patients with chronic kidney disease 5D.
Date of disclosure of the study information 2014/08/11
Last modified on 2015/08/08

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Basic information
Public title Effect of Febuxostat on Flow Mediated Diameter in hyperuricemia patients with chronic kidney disease 5D.
Acronym Effect of Febuxostat on Flow Mediated Diameter. (FFMD-5D study)
Scientific Title Effect of Febuxostat on Flow Mediated Diameter in hyperuricemia patients with chronic kidney disease 5D.
Scientific Title:Acronym Effect of Febuxostat on Flow Mediated Diameter. (FFMD-5D study)
Region
Japan

Condition
Condition hyperuricemia
Classification by specialty
Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effect of febuxostat on vascular endothelial function in hemodialysis patients with hyperuricemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Flow Mediated Diameter:FMD
Key secondary outcomes the change of FMD.
the change of serum uric acid level
achievement rate of the target serum uric acid level(<6.0mg/dl)
oxidative stress
inflammatory maker
gouty attack
adverse event

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 febuxostat administration
Interventions/Control_2 life habit improvement
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients with maintenance hemodailaysis must match all conditions below.
Patients older than 20 years old.
Patients with serum uric acid level over 7.0mg/dl.
Patients agreed with consent form.
Key exclusion criteria Patients who take allopurinol, probenecid, bucolome, febuxostat.
Patients with history of hypersensitivity to febuxostat.
Patients who take mercaptopurine, azathiopurine, pyrazinamide or ethambutol.
Patients participant to other clinical trials within recent 4 weeks.
Patients judged not to be suitable as a subject by attending doctor.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukio Tsuruta
Organization Tsuruta clinic
Division name Dialysis center
Zip code
Address 2-67-8, Itabashi, Itabashi-ku, Tokyo, Japan
TEL 03-5375-7600
Email info@keitenkai.net

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Tsuruta
Organization Tsuruta clinic
Division name Dialysis center
Zip code
Address 2-67-8, Itabashi, Itabashi-ku, Tokyo, Japan
TEL 03-5375-7600
Homepage URL
Email yuki@kb4.so-net.ne.jp

Sponsor
Institute Tsuruta clinic
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We randomly assigned 53 hemodialysis patients with hyperuricemia to a febuxostat (10mg daily) group and a control group. Flow-mediated dilation increased from 5.3% to 8.9 in the febuxostat group but did not change significantly in the control group. Treatment with febuxostat resulted in a significant decrease in serum UA level and a significant decrease in MDA-LDL compared with baseline, but no significant difference was observed in hsCRP level or blood pressure. No significant differences were observed in the control group.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2014 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 07 Day
Last modified on
2015 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017192


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