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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006494
Receipt No. 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

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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
Email

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
Email kidney@gh.opho.jp

Sponsor
Institute Department of Kidney Disease and Hypertension
Osaka General Medical Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007704

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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