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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name