UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006494 |
|---|---|
| Receipt number | R000007704 |
| Scientific Title | Predictive marker of responsiveness of anemia in non-dialytic CKD to long acting erythropoiesis stimulating agent |
| Date of disclosure of the study information | 2011/10/07 |
| Last modified on | 2019/10/12 12:02:54 |
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Basic information
Public title
Predictive marker of responsiveness of anemia in non-dialytic CKD to long acting erythropoiesis stimulating agent
Acronym
Responsivenss of CKD anemia for long acting ESA
Scientific Title
Predictive marker of responsiveness of anemia in non-dialytic CKD to long acting erythropoiesis stimulating agent
Scientific Title:Acronym
Responsivenss of CKD anemia for long acting ESA
Region
| Japan |
Condition
Condition
non-dialytic chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploring predictive marker of responsiveness of CKD anemia for long acting erythropoiesis stimulating agents
Basic objectives2
Others
Basic objectives -Others
Exploring clinical index
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Increase in hemoglobin after 8 weeks from starting ESA
Key secondary outcomes
Increase in hemoglobin above the level at which ESA is recommended to stop in the guideline
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
long acting erythropoiesis stimulating agent
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
| 15 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Anemia (hemoglobin < 11.0g/dL in more than two measurement) due to chronic kidney disease
Key exclusion criteria
1 Severe hypertension
2 Congestive heart failure (NYHE III or IV)
3 Myocardial infarction, pulmonary infarction of cerebral infarction within 6 months
4 Active infection
5 Malignant tumor and hematological disease
6 erythropoietin use within 6 months
7 Transfusion within 6 months
8 Patients whom doctor judged inappropriate as participant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Shoji |
Organization
Osaka General Medical Center
Division name
Department of Kidney Disease and Hypertension
Zip code
Address
3-1-56, Bandai-Higashi, Sumiyoshi-ku, Osaka City, Japan
TEL
06-6692-201
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka General Medical Center
Division name
Department of Kidney Disease and Hypertension
Zip code
Address
TEL
Homepage URL
kidney@gh.opho.jp
Sponsor or person
Institute
Department of Kidney Disease and Hypertension
Osaka General Medical Center
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
| 2011 | Year | 10 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 06 | Day |
Last modified on
| 2019 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007704
| 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 |
