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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003891
Receipt No. R000003304
Scientific Title Examination concerning utility and safety of Cilostazol use in patients with PAD conplicated to CKD
Date of disclosure of the study information 2010/07/15
Last modified on 2010/07/08

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Basic information
Public title Examination concerning utility and safety of Cilostazol use in patients with PAD conplicated to CKD
Acronym Examination concerning utility and safety of Cilostazol use in patients with PAD conplicated to CKD
Scientific Title Examination concerning utility and safety of Cilostazol use in patients with PAD conplicated to CKD
Scientific Title:Acronym Examination concerning utility and safety of Cilostazol use in patients with PAD conplicated to CKD
Region
Japan

Condition
Condition PAD with CKD
Classification by specialty
Cardiology Nephrology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the regression of renal function, albuminuria and endothelial dysfunction of Cilostazol comparing to aspirin in patients with PAd with CKD
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes renal function(eGFR,cCRe), albuminuria and endothelial dysfunction
Key secondary outcomes intima-media thickness(IMT), ABI,TBI,serum lipid marker

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 cilostazol
Interventions/Control_2 aspirin
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)Patients with eGFR<60ml/min/1.73m2, or continues protein urea for three months or more
2)Patients with ABI<0.9, or TBI<0.7
3)Patients with agreement by document
Key exclusion criteria 1)Nephrotic syndrome
2)active bleeding
3)allergy for cilostazol and aspirin
4)platelet dysfunction
5)age under 20y.o.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukio Yuzawa
Organization Nagoya university graduate school of medicine
Division name Department of Nephrology
Zip code
Address Turumai-tyo 65, syouwa-ku, Nagoya
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagoya university graduate school of medicine
Division name Departmrnt of CKD initiatives
Zip code
Address
TEL 052-744-5502
Homepage URL
Email

Sponsor
Institute Departmrnt of CKD initiatives,Nagoya university graduate school of medicine
Institute
Department

Funding Source
Organization Department of Nephrology,Nagoya university graduate school of medicine
Organization
Division
Category of Funding Organization
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
2010 Year 07 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
2009 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2010 Year 07 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
2010 Year 07 Month 08 Day
Last modified on
2010 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003304

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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