UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005169 |
|---|---|
| Receipt number | R000006138 |
| Scientific Title | Efficacy of prostaglandin E1 (alprostadil alfadex) in hemodialysis patients with peripheral arterial disease (PAD): Examination of the therapeutic effect based on measurement of skin perfusion pressure (SPP) |
| Date of disclosure of the study information | 2011/03/03 |
| Last modified on | 2011/03/02 12:15:40 |
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Basic information
Public title
Efficacy of prostaglandin E1 (alprostadil alfadex) in hemodialysis patients with peripheral arterial disease (PAD): Examination of the therapeutic effect based on measurement of skin perfusion pressure (SPP)
Acronym
Efficacy of prostaglandin E1 (alprostadil alfadex) in hemodialysis patients with PAD
Scientific Title
Efficacy of prostaglandin E1 (alprostadil alfadex) in hemodialysis patients with peripheral arterial disease (PAD): Examination of the therapeutic effect based on measurement of skin perfusion pressure (SPP)
Scientific Title:Acronym
Efficacy of prostaglandin E1 (alprostadil alfadex) in hemodialysis patients with PAD
Region
| Japan |
Condition
Condition
Peripheral Arterial Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The goal of the study was to evaluate the efficacy of prostaglandin E1 (PGE1) injection (brand name: prostaglandin for injection, generic name: alprostadil alfadex for injection) for improving lower extremity arterial blood flow using measurement of skin perfusion pressure (SPP)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amelioration of SPP
Key secondary outcomes
Results from a questionnaire survey and a visual analogue scale (VAS)
Improvement of subjective symptoms, safety, and changes in blood pressure during hemodialysis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Prostaglandin E1 (PGE1) injection (brand name: prostaglandin for injection, generic name: alprostadil alfadex for injection)
Interventions/Control_2
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 20 years old or older
2. Patients undergoing maintenance hemodialysis
3. No criteria regarding sex and underlying disease
4. Patients who provided written informed consent
Key exclusion criteria
1. Patients with no symptoms of PAD (cold feeling, sense of numbness, intermittent claudication, pain during rest, etc.)
2. Patients under treatment with PGE1
3. Patients with symptoms of inflammatory, coronary artery, or cerebrovascular disease within the previous 3 months
4. Patients with severe hepatic or cardiac disease
5. Patients under treatment for a malignant tumor or those who had received treatment for a malignant tumor within the previous 5 years
6. Pregnant patients, lactating patients, patients who showed signs of pregnancy, and patients who intended to become pregnant
7. Patients with a history of hypersensitivity to PGE1 injection
8. Other patients who were judged to be inappropriate for the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Oguchi |
Organization
Ikegami General hospital
Division name
Renal unit
Zip code
Address
6-1-19 ikegami,ota-ku,Tokyo
TEL
03-3752-3151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ikegami General hospital
Division name
Renal unit
Zip code
Address
TEL
03-3752-3151
Homepage URL
Sponsor or person
Institute
Ikegami General hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 03 | Month | 03 | 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
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 02 | Day |
Last modified on
| 2011 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006138
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
