UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001575
Receipt number 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 15:42:02

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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 or person

Institute

Society for Research on chronic kidney disease and hyperuricemia

Institute

Department

Personal name



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

Value
https://center6.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