UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Consider reduction of dialysis work on On-line HDF implementation ~ From timing of drug administration ~
Title of the study (Brief title)	HDF TD study
Region	Japan

Condition
Condition	Patients in need of treatment for renal anemia due to ESA administration in patients under On-line HDF treatment
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, administration of epoetin beta (genetical recombination), darbepoetin alfa (genetical recombination), epoetin beta pegol (genetical recombination) was administered to patients with renal anemia during on-line HDF treatment from the time of on-line HDF completion Changes during on-line HDF and examines whether the target hemoglobin (Hb) maintenance rate and ESA dose are affected by the change in the timing of ESA administration.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Administration of 30 (30 each) between the three groups of epoetin beta (genetical recombination) group, darbepoietin alpha (genetical recombination) group and epoetin beta pegol (gene recombination) group was administered on-line from the end of on-line HDF Change the target hemoglobin (Hb) maintenance rate and ESA dose during the HDF execution (1 to 2 hours after the start) to examine whether there is an influence due to the change of the ESA administration timing.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine Behavior,custom
Interventions/Control_1	Epoetin beta (genetical recombination) group Change ESA administration from On-line HDF end to on-line HDF enforcement (1 to 2 hours after start).
Interventions/Control_2	Darbepoietin alpha (genetical recombination) group Change ESA administration from On-line HDF end to on-line HDF enforcement (1 to 2 hours after start).
Interventions/Control_3	Epoetin beta pegol (genetical recombination) group Change ESA administration from On-line HDF end to on-line HDF enforcement (1 to 2 hours after start).
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) The age at the time of acquiring consent is between 20 and 85 years old (2) Renal anemia treatment by ESA administration is under way (3) More than 3 months have passed since On-line HDF implementation (4) ESA has been administered to achieve an anemia improvement target (Hb value of 10 g / dl or more, less than 12 g / dl) continuously for 3 months or more (5) Patient consent was obtained from the patient himself / herself for this research participation
Key exclusion criteria	1) Patients with anemia due to factors other than renal anemia (2) Patients with hypersensitivity to epoetin beta (genetical recombination), darbepoietin alpha (genetical recombination), epoetin beta pegol (genetical recombination) (3) Patients with malignant tumors (4) Pregnant women or patients who may be pregnant, breastfeeding, or who desire pregnancy during research participation (women only) (5) Other Research Responsibilities (In charge) Patients judged by doctors as inappropriate for this study
Target sample size	90

Research contact person
Name of lead principal investigator	Takeshi Onogi
Organization	Kaikoukai Medical Foundation Hekikai Kyoritsu Clinic
Division name	Kidney Internal Medicine
Address	Aichi Prefecture Anjo City Takatana Town Nakashima 115-1
TEL	0566-73-2710
Email	tonogi@touseki.jp

Public contact
Name of contact person	Hiroshi Sakurai
Organization	Kaikoukai Medical Foundation
Division name	Dialysis Medical Division
Address	Aichi prefecture Nagoya city Nakagawa ku Hokke 1 - 161
TEL	052-363-7211
Homepage URL
Email	hrsakurai@kaikou.or.jp

Sponsor
Institute	Kaikoukai Medical Foundation
Institute
Department

Funding Source
Organization	Kaikoukai Medical Foundation
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 06 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 01 Month 18 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry	2018 Year 06 Month 15 Day
Date trial data considered complete	2018 Year 06 Month 20 Day
Date analysis concluded	2018 Year 06 Month 21 Day

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

Management information
Registered date	2017 Year 03 Month 02 Day
Last modified on	2018 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030288