UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009262 |
|---|---|
| Receipt number | R000010875 |
| Scientific Title | effects of Uric-acid-lowering agent, FebuxOstat on subclinical inflammation in patients with hyperuricemia (UFO study) |
| Date of disclosure of the study information | 2012/11/05 |
| Last modified on | 2015/05/07 14:10:35 |
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Basic information
Public title
effects of Uric-acid-lowering agent, FebuxOstat on subclinical inflammation in patients with hyperuricemia (UFO study)
Acronym
effects of Uric-acid-lowering agent, FebuxOstat on subclinical inflammation in patients with hyperuricemia (UFO study)
Scientific Title
effects of Uric-acid-lowering agent, FebuxOstat on subclinical inflammation in patients with hyperuricemia (UFO study)
Scientific Title:Acronym
effects of Uric-acid-lowering agent, FebuxOstat on subclinical inflammation in patients with hyperuricemia (UFO study)
Region
| Japan |
Condition
Condition
hyperuricemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of febuxostat on markers of metabolic syndrome and atherosclerosis, including high sensitivity C-reactive protein, in patients with hyperuricemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum high sensitivity C-reactive protein (CRP)
Key secondary outcomes
(1) Changes of HOMA-IR between two groups
(2) Changes of IMT, PWV
(3) Effects on factors of metabolic syndrome (abdominal, blood pressure, fat, blood glucose)
(4) Change of serum uric acid levels and achiving less than 6.0mg/dl of uric acid levels,
(5) Changes of eGFR
(6) Changes of albuminuria/creatinine
(7) Changes of serum and urine biomarkers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
febuxostat + life style modification
Interventions/Control_2
life style modification
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
| 100 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) serum urate levels higher than 7.0 mg/dl
(2) not treated with urate reducing drugs for 1 month
(3) other complications including hypertension, dyslipidemia and diabetes are in stable
(4)written informed consent obtained from the participants
Key exclusion criteria
(1) patients with history of gout
(2) patients with malignancy, or other serious illness
(3) patients with allergy to febuxostat
(4) patients treated with mercaptopurine or azathioprine
(5) patients not recognized as appropriate to participate
(6) patients under insulin treatment
(7) serum creatinine levels higher than 1.5 mg/dl
(8) patients with inflammatory disease such as rheumatic diseases or inflammatory bowel diseases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamamoto, Tetsuya |
Organization
Hyogo College of Medicine
Division name
Department of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo 663-8501
TEL
0798-45-6473
tetsuya@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koyama, Hidenori |
Organization
Hyogo College of Medicine
Division name
Department of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo 663-8501
TEL
0798-45-6473
Homepage URL
hkoyama@hyo-med.ac.jp
Sponsor or person
Institute
UFO study Investigators
Institute
Department
Personal name
Funding Source
Organization
TEIJIN Pharmaceutical
Organization
Division
Category of Funding Organization
Profit organization
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
| 2012 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | 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
| 2012 | Year | 11 | Month | 05 | Day |
Last modified on
| 2015 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010875
