UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021774 |
|---|---|
| Receipt number | R000025106 |
| Scientific Title | Renal anemia treatment in chronic kidney disease patients |
| Date of disclosure of the study information | 2016/04/04 |
| Last modified on | 2017/11/28 15:16:24 |
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Basic information
Public title
Renal anemia treatment in chronic kidney disease patients
Acronym
Renal anemia treatment in chronic kidney disease patients
Scientific Title
Renal anemia treatment in chronic kidney disease patients
Scientific Title:Acronym
Renal anemia treatment in chronic kidney disease patients
Region
| Japan |
Condition
Condition
Renal anemia in chronic kidney disease patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Te determine the effect of anemia treated by erythropoiesis-stimulating agents (ESAs) on the onset of cardiovascular events and the survival rate
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the incidence of CVEs and the survival rate during ESAs administration in three kinds of ESAs [epoetin(EPO), darbepoetin alpha(DPO), and epoetin beta pegol(EPObp)]
Key secondary outcomes
To compare the frequency of adverse events and degree of increase in hemoglobin (Hb) in three kinds of ESAs (EPO, DPO, and EPObp)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Chronic kidney disease patients with renal anemia that are required to treat by erythropoiesis-stimulating agents.
Key exclusion criteria
Patients complicated with potential diseases causing anemia such as hemorrhagic disease, hematological disease, or carcinoma.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Kuwahara |
Organization
Shuuwa General Hospital
Division name
Department of Nephrology
Zip code
Address
1200 Yahara-Shinden, Kasukabe, Saitama 344-0035, Japan
TEL
048-737-2121
kuwaharam@shuuwa-gh.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Kuwahara |
Organization
Shuuwa General Hospital
Division name
Department of Nephrology
Zip code
Address
1200 Yahara-Shinden, Kasukabe, Saitama 344-0035, Japan
TEL
048-737-2121
Homepage URL
kuwaharam@shuuwa-gh.or.jp
Sponsor or person
Institute
Shuuwa General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 04 | Month | 04 | 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
This research was formulated and promoted by Mr. Michio Kuwabara (M.K.), the research director. However, M.K. moved from Shuuwa General Hospital to another hospital from April 1, 2017 because of personnel change. M.K. asked seven colleagues in Shuuwa General Hospital about intention to continue this research, but no one had the intention for various reasons. Therefore, M.K. had to cancel this research.
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
Terminated
Date of protocol fixation
| 2005 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 04 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study. Among the patients that visited the Department of Nephrology of Shuuwa General Hospital after April 4, 2005, all patients that fulfilled the inclusion criteria were enrolled in this study.
Management information
Registered date
| 2016 | Year | 04 | Month | 04 | Day |
Last modified on
| 2017 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025106
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
