UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of febuxostat in post-nephrectomy patients with kidney tumor
Title of the study (Brief title)	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

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	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

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	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	Haruhito Azuma
Organization	Osaka Medical College
Division name	Urology
Address	Daigakumachi 2-7
TEL	072-683-1221
Email	uro001@osaka-med.ac.jp

Public contact
Name of contact person	Teruo Inamoto
Organization	Osaka Medical College
Division name	Urology
Address	Daigakumachi 2-7
TEL	072-683-1221
Homepage URL
Email	tinamoto@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
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	Osaka Medical College
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 11 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015926