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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001575
Receipt No. R000001898
Scientific Title Uric acid Reduction Ameliorates Transition to End-stage renal disease Study (URATE Study)
Date of disclosure of the study information 2008/12/15
Last modified on 2009/11/05

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Basic information
Public title Uric acid Reduction Ameliorates Transition to End-stage renal disease Study (URATE Study)
Acronym URATE Study
Scientific Title Uric acid Reduction Ameliorates Transition to End-stage renal disease Study (URATE Study)
Scientific Title:Acronym URATE Study
Region
Japan

Condition
Condition hyperuricemia
chronic kidney disease (CKD)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of benzbromarone treatment in patients with hyperuricemia associated CKD
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Death
Doubling of serum creatinine
Dialysis
Key secondary outcomes

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 administration of benzbromarone
Interventions/Control_2 unadministration of benzbromarone
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 -serum creatinine level &#8805; 2.2mg/dl(male), &#8805; 1.7mg/dl(female)
serum urate level &#8805; 7mg/dl

-without acute alteration in renal function

-stabilized patient under treatment within the CKD clinical practice guideline (by Japanese Society of Nephrology)
Key exclusion criteria -patient with contraindications to benzbromarone

-patient who takes warfarin
Target sample size 660

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Syunya Uchida
Organization Teikyo University
Division name Department of internal medicine
Zip code
Address 2-11-1 Kaga Itabashiku Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Matsuda
Organization Teikyo University
Division name EBM Center
Zip code
Address 2-11-1 Kaga Itabashiku Tokyo
TEL
Homepage URL
Email URATE-Office@jhbri.com

Sponsor
Institute Society for Research on chronic kidney disease and hyperuricemia
Institute
Department

Funding Source
Organization The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2008 Year 12 Month 15 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
2008 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 12 Month 15 Day
Last modified on
2009 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001898

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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