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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000527
Receipt No. R000000640
Scientific Title Randomized trial to evaluate the renoprotective effect of cilostazol on chronic kidney disease patients with arteriosclerosis obliterans
Date of disclosure of the study information 2006/11/22
Last modified on 2011/06/24

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Basic information
Public title Randomized trial to evaluate the renoprotective effect of cilostazol on chronic kidney disease patients with arteriosclerosis obliterans
Acronym Cilostazol for chronic kidney disease with arteriosclerosis obliterans: randomized trial(CCKDA trial)
Scientific Title Randomized trial to evaluate the renoprotective effect of cilostazol on chronic kidney disease patients with arteriosclerosis obliterans
Scientific Title:Acronym Cilostazol for chronic kidney disease with arteriosclerosis obliterans: randomized trial(CCKDA trial)
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the renoprotective effect of cilostazol on chronic kidney disease patients with arteriosclerosis obliterans
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in glomerular filtration rate
and renal plasma flow
Key secondary outcomes Change in pulse wave velocity and von Willebrand factor
Occurrence of cardiovascular event

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 Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Cilostazol 100mg and Aspirin 100mg daily
Interventions/Control_2 Aspirin 100mg daily
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Chronic kidney disease patients (CKD stage 2-4) with arteriosclerosis obriterans
Key exclusion criteria Patients with allergy for cilostazol or aspirin, bleeding tendency, or pregnancy. Patients with other platelet aggregation inhibitor or anticoagulant drug. Patients who are inadequate to entry this study by physicians in charge.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunihiro Yamagata
Organization Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences,University of Tsukuba
Division name Division of Nephrology
Zip code
Address 1-1-1,Ten-nodai,Tsukuba,Ibaraki
TEL 029-853-3202
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chie Saito
Organization Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences,University of Tsukub
Division name Division of Nephrology
Zip code
Address 1-1-1,Ten-nodai,Tsukuba,Ibaraki
TEL 029-853-3202
Homepage URL
Email kidney@md.tsukuba.ac.jp

Sponsor
Institute Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences,University of Tsukuba
Institute
Department

Funding Source
Organization Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences,University of Tsukuba
Organization
Division
Category of Funding Organization Self funding
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
2006 Year 11 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2006 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2006 Year 12 Month 01 Day
Last follow-up date
2008 Year 11 Month 01 Day
Date of closure to data entry
2009 Year 10 Month 01 Day
Date trial data considered complete
2009 Year 10 Month 01 Day
Date analysis concluded
2010 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 11 Month 22 Day
Last modified on
2011 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000640

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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