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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026361
Receipt No. R000030288
Scientific Title Consider reduction of dialysis work on On-line HDF implementation ~ From timing of drug administration ~
Date of disclosure of the study information 2017/06/01
Last modified on 2018/09/21

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Basic information
Public title Consider reduction of dialysis work on On-line HDF implementation ~ From timing of drug administration ~
Acronym HDF TD study
Scientific Title Consider reduction of dialysis work on On-line HDF implementation ~ From timing of drug administration ~
Scientific Title:Acronym 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
1st name
Middle name
Last name Takeshi Onogi
Organization Kaikoukai Medical Foundation Hekikai Kyoritsu Clinic
Division name Kidney Internal Medicine
Zip code
Address Aichi Prefecture Anjo City Takatana Town Nakashima 115-1
TEL 0566-73-2710
Email tonogi@touseki.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Sakurai
Organization Kaikoukai Medical Foundation
Division name Dialysis Medical Division
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2017 Year 06 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 Preinitiation
Date of protocol fixation
2017 Year 01 Month 18 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000030288

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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