UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029360 |
|---|---|
| Receipt number | R000033531 |
| Scientific Title | Usefulness of topical heparinoid in the treatment of asteatosis in hemodialyzed patients |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2018/08/02 17:51:45 |
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Basic information
Public title
Usefulness of topical heparinoid in the treatment of asteatosis in hemodialyzed patients
Acronym
Usefulness of topical heparinoid in the treatment of asteatosis in hemodialyzed patients
Scientific Title
Usefulness of topical heparinoid in the treatment of asteatosis in hemodialyzed patients
Scientific Title:Acronym
Usefulness of topical heparinoid in the treatment of asteatosis in hemodialyzed patients
Region
| Japan |
Condition
Condition
asteatosis in hemodialyzed patient
Classification by specialty
| Nephrology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of the skin care with topical heparinoid in the treatment of asteatosis in hemodialyzed patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The water content of the stratum corneum at week4
Key secondary outcomes
Efficacy (The water content of the stratum corneum, pruritus, DLQI), Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Base treatment + heparinoid(Initial to week2)
Interventions/Control_2
Base treatment + heparinoid(Initial to week8)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Chronic renal failure patients who regularly receive hemodialysis two or three times a week and are not likely to have a serious treatment change or acute symptoms during the study period.
(2) Patients with asteatosis at hypochondriac region at time of initial of treatment
(3) Patients with pruritus at time of initial of treatment
(4) Patients who signed informed consent.
(5) Patients aged 20 to 80 years at time of signing the consent form
(6) Patients of either sex
Key exclusion criteria
(1) Patients who received heparinoid- or urea -containing drugs, or petrolatum within three weeks before signing the consent form.
(2) Patients with/ with the past of extensive complications of the skin (burn, psoriasis etc.)
(3) Patients with allergy to heparinoid
(4) Patients with hemorrhagic blood disease (hemophilia, thrombocytopenia, purpura etc.)
(5) Patients who are expected a few bleeding causes a serious result.
(6) Patients who are pregnant, or possibly pregnant women.
(7)Patients who participated in other clinical study within 4 months before starting study.
(8) Patients who are unsuitable to the study at the investigator's discretion.
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi tsuruoka |
Organization
Nippon medical school hospital
Division name
Nephrology
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
tsuruoka@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuichi tsuruoka |
Organization
Nippon medical school hospital
Division name
Nephrology
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
tsuruoka@nms.ac.jp
Sponsor or person
Institute
Nippon medical school hospital
Institute
Department
Personal name
Funding Source
Organization
Maruho Co., Ltd.
Organization
Division
Category of Funding Organization
Profit 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
日本医科大学 腎クリニック（東京都）、ほか
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 01 | 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
| 2017 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | 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
| 2017 | Year | 09 | Month | 30 | Day |
Last modified on
| 2018 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033531
| 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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