UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014787 |
|---|---|
| Receipt number | 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 01:15:39 |
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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
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
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
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
yuki@kb4.so-net.ne.jp
Sponsor or person
Institute
Tsuruta clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017192
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
