UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026361 |
|---|---|
| Receipt number | 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 16:25:57 |
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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
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
hrsakurai@kaikou.or.jp
Sponsor or person
Institute
Kaikoukai Medical Foundation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030288
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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