UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003891 |
|---|---|
| Receipt number | 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 19:08:34 |
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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
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
Sponsor or person
Institute
Departmrnt of CKD initiatives,Nagoya university graduate school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003304
