UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008727 |
|---|---|
| Receipt number | R000010227 |
| Scientific Title | Effect of febuxostat on serum uric acid and renal function in patients with hyperuricemia. -open label, active (allopurinol)-controlled clinical study- |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2019/08/26 16:38:34 |
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Basic information
Public title
Effect of febuxostat on serum uric acid and renal function in patients with hyperuricemia. -open label, active (allopurinol)-controlled clinical study-
Acronym
Effect of febuxostat on serum uric acid and renal function
Scientific Title
Effect of febuxostat on serum uric acid and renal function in patients with hyperuricemia. -open label, active (allopurinol)-controlled clinical study-
Scientific Title:Acronym
Effect of febuxostat on serum uric acid and renal function
Region
| Japan |
Condition
Condition
Hyperuricemia
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the effect of febuxostat on serum uric acid and estimated GFR in patients treated with allopurinol, and compare them between allopurinol and febuxostat.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change ratio of serum uric acid
eGFR change from baseline
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is 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
Allopurino50-100mg
Interventions/Control_2
Febuxostat10-20mg
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
(1)Patients with hyperuricemia and renal dysfunction
(2)Patients who treated with allopurinol, and their levels of serum uric acid are more than 6.0mg/dl
(3)eGFR<60ml/min/1.73m2
Key exclusion criteria
(1)Febuxostat sensitivity
(2)Hemodialysis patients
(3)Secondary hyperuricemia
(4)SBP>=160 or DBP>=100
(5)AST and ALT levels less than 2-times the upper limit of normal
(6)Newly onset CAD and CVD within 6 months
(7)Treated with mercaptopurine and azathioprine
(8)During breast-feeding
(9)Doctor considers inappropriate as subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohito Gohda |
Organization
Juntendo University Faculty of Medicine
Division name
Division of Nephrology, Department of Internal Medicine
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University Faculty of Medicine
Division name
Division of Nephrology, Department of Internal Medicine
Zip code
Address
TEL
03-5802-1065
Homepage URL
Sponsor or person
Institute
Division of Nephrology, Department of Internal Medicine, Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Department of Internal Medicine, Juntendo University Faculty of Medicine
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
| 2012 | Year | 09 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 20 | Day |
Last modified on
| 2019 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010227
