UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of topical heparinoid in the treatment of asteatosis in hemodialyzed patients
Title of the study (Brief title)	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	Shuichi tsuruoka
Organization	Nippon medical school hospital
Division name	Nephrology
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL	03-3822-2131
Email	tsuruoka@nms.ac.jp

Public contact
Name of contact person	Shuichi tsuruoka
Organization	Nippon medical school hospital
Division name	Nephrology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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