UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006023 |
|---|---|
| Receipt number | R000007126 |
| Scientific Title | A clinical study for availability of algorism to control of anemia of hemodialysis patients |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2011/10/05 15:46:09 |
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Basic information
Public title
A clinical study for availability of algorism to control of anemia of hemodialysis patients
Acronym
Algorism study for anemia of HD patients
Scientific Title
A clinical study for availability of algorism to control of anemia of hemodialysis patients
Scientific Title:Acronym
Algorism study for anemia of HD patients
Region
| Japan |
Condition
Condition
renal anemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our aim is to evaluate the availability of algorism to control of anemia confirmed in hemodialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
compliance rates for target and hemoglobin variability
Key secondary outcomes
doses of erythropetin administration
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
algorism
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
Patients treated with erythropoietin agent for more than 6 months under dialysis treatment
Key exclusion criteria
patients with bleeding tendency
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Nishi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Nephrology and Kidney Center
Zip code
Address
Kusunokimachi 7-5-2, Kobe city, Hygo prefecture
TEL
078-382-6500
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Nishi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Nephrology and Kidney Center
Zip code
Address
Kusunokimachi 7-5-2, Kobe city, Hygo prefecture
TEL
078-382-6500
Homepage URL
snishi@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Nephrology and Kidney Center
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology and Kidney Center
Kobe University Graduate School of Medicine
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
神戸大学附属病院、千船病院(大阪府)、原泌尿器科病院(兵庫県)、甲南病院(兵庫県)、六甲アイランド病院(兵庫県)、西脇市民病院(兵庫県)、高砂病院(兵庫県)、西明石医療センター(兵庫県)
Kobe university hospital, Chifune hospital, Hara Genitourinary hospital, Konan hospital, Rokko Island hospital. Nishiwaki city hospital, Takasago hospital, Nishi-Akashi medical center
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | 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
| 2011 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 22 | Day |
Last modified on
| 2011 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007126
