UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective study of Erythropoiesis STimulating Agent dose ReducTion on hemodialysis patients by using anti-thrombogenic membrane
Title of the study (Brief title)	RESTART Study
Region	Japan

Condition
Condition	Chronic renal disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is examined whether switching to anti-thrombogenic dialyzer affects the responsibility to ESA.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Responsibility for erythropoiesis stimulating agent 6 or 12 months after the beginning of observation.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Outpatients who had been treated with more than 4h dialysis three times a week. 2) Patients who had been treated more than 3 months with polysulfone type dialyzers excluding NV, (their dialysis vintages are more than 3 months). 3) Patients who had been more than 20 years old. 4) Patients to whom erythropoiesis stimulating agent had been prescribed
Key exclusion criteria	For 3 months before the beginning of observation and during observation period, patients who had fulfilled conditions below were excluded. 1) Patients who had been treated with other renal insufficiency therapies, continuous ambulatory peritoneal dialysis and hemodiafiltration, excluding hemodialysis. 2) Patients to whom Epoetin Beta Pegol (CERA) had been prescribed. 3) Patients to whom blood transfusion had been conducted. 4) Patients who had been hospitalized for more than 2 weeks. 5) Patients who had become pregnant or given birth. 6) Patients who had hematologic diseases excluding renal anemia. 7) Patients who had been treated for a malignant tumor. 8) Patients who is judged as the inadequate subject of this study by the doctor.
Target sample size	400

Research contact person
Name of lead principal investigator	Takatoshi Kakuta
Organization	Tokai University Hachioji Hospital
Division name	ivision of Nephrology, Endocrinology and Metabolism
Address	1838 Ishikawa-nachi, Hachioji-shi, Tokyo
TEL	042-639-1111
Email	kakuta@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	Takatoshi Kakuta
Organization	Tokai University Hachioji Hospital
Division name	ivision of Nephrology, Endocrinology and Metabolism
Address	1838 Ishikawa-nachi, Hachioji-shi, Tokyo
TEL	042-639-1111
Homepage URL
Email	kakuta@is.icc.u-tokai.ac.jp

Sponsor
Institute	RESTART Study group
Institute
Department

Funding Source
Organization	TORAY Industries Inc.
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

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 10 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	In previous prospective clinical study, TORAYLIGHT NV had a possibility to reduce erythropoiesis stimulating agent.

Management information
Registered date	2015 Year 07 Month 27 Day
Last modified on	2018 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021341