UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003597 |
|---|---|
| Receipt number | R000004366 |
| Scientific Title | A prospective, randomized, open-label clinical trial evaluating the effect of sarpogrelate hydrochloride on skin perfusion pressure in hemodialysis patients with arteriosclerosis obliterans |
| Date of disclosure of the study information | 2010/05/17 |
| Last modified on | 2010/05/11 19:07:37 |
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Basic information
Public title
A prospective, randomized, open-label clinical trial evaluating the effect of sarpogrelate hydrochloride on skin perfusion pressure in hemodialysis patients with arteriosclerosis obliterans
Acronym
A prospective, randomized, open-label clinical trial evaluating the effect of sarpogrelate hydrochloride on skin perfusion pressure in hemodialysis patients with arteriosclerosis obliterans
Scientific Title
A prospective, randomized, open-label clinical trial evaluating the effect of sarpogrelate hydrochloride on skin perfusion pressure in hemodialysis patients with arteriosclerosis obliterans
Scientific Title:Acronym
A prospective, randomized, open-label clinical trial evaluating the effect of sarpogrelate hydrochloride on skin perfusion pressure in hemodialysis patients with arteriosclerosis obliterans
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of sarpogrelate hydrochloride on skin perfusion pressure in hemodialysis patients with arteriosclerosis obliterans
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in SPP
Key secondary outcomes
Improvement of symptoms of ASO
Change in ABI
Adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients will be randomly assigned either to sarpogrelate hydrochloride or conventional therapy.
Sarpogrelate hydrochloride 300mg daily for a year
Interventions/Control_2
Conventional therapy
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)Hemodialysis patients with arteriosclerosis obliterans(Fontaine1)2)SPP<75mmHg at the commencement
Key exclusion criteria
1)Patients with revascularization 2)Patients who is taking antiplatelet agents excluding low-dose aspirin and/or thienopyridine derivatives 3)Patients with warfarin 4)Patients with coronary artery disease and/or cerebrovascular disease within three months 5)Patients with bleeding or bleeding tendency 6)Patients with severe hepatic dysfunction and/or cardiac dysfunction 7)Patients with malignancy 8)Pregnant or lactating women, or women who wish to become pregnant 9)Patients with allergy to sarpogrelate hydrochloride 10)Patients who were not suitable for this trial judged by the attending doctor
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takatoshi Kakuta |
Organization
Department of Internal Medicine, Tokai University School of Medicine
Division name
Kidney. Center
Zip code
Address
143, Shimokasuya, Isehara, Kanagawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takatoshi Kakuta |
Organization
Department of Internal Medicine, Tokai University School of Medicine
Division name
Kidney. Center
Zip code
Address
143, Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
Sponsor or person
Institute
Department of Internal Medicine, Tokai University School
Institute
Department
Personal name
Funding Source
Organization
None
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
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
東海大学医学部付属病院(神奈川県）、望星平塚クリニック（神奈川県）
本厚木メディカルクリニック（神奈川県）、誠知クリニック（神奈川県）
望星藤沢クリニック（神奈川県）、望星大根クリニック（神奈川県）
厚木クリニック（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
| 2010 | Year | 05 | Month | 11 | Day |
Last modified on
| 2010 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004366
