UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013645 |
|---|---|
| Receipt number | R000015926 |
| Scientific Title | Effect of febuxostat in post-nephrectomy patients with kidney tumor |
| Date of disclosure of the study information | 2014/04/04 |
| Last modified on | 2016/04/15 19:48:53 |
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Basic information
Public title
Effect of febuxostat in post-nephrectomy patients with kidney tumor
Acronym
febuxostat for renal dysfunction
Scientific Title
Effect of febuxostat in post-nephrectomy patients with kidney tumor
Scientific Title:Acronym
febuxostat for renal dysfunction
Region
| Japan |
Condition
Condition
kidney tumor
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of febuxostat in patients who underwent nephrectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum urinary acid
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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. Agreement with informed consent
2. Aged 20 or above
3. Serum UA at lest 7 mg/dl
Key exclusion criteria
1. Patient with gout
2. Transaminase level two times upper limit or greater
3. Allergy to drug
4. Taking mercaptopurine or azathioprine
5. Pregnant
6. Physician's decision
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhito Azuma |
Organization
Osaka Medical College
Division name
Urology
Zip code
Address
Daigakumachi 2-7
TEL
072-683-1221
uro001@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruo Inamoto |
Organization
Osaka Medical College
Division name
Urology
Zip code
Address
Daigakumachi 2-7
TEL
072-683-1221
Homepage URL
tinamoto@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Other
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 | 04 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2014 | Year | 04 | Month | 04 | Day |
Last modified on
| 2016 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015926
