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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029360
Receipt No. 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

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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
Email 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
Email tsuruoka@nms.ac.jp

Sponsor
Institute Nippon medical school hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033531

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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