UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009467 |
|---|---|
| Receipt number | R000011121 |
| Scientific Title | Chronic kidney disease-A Prospective study of Treatment for Renal Anemia on Prognosis in hemodialysis patients study. |
| Date of disclosure of the study information | 2012/12/10 |
| Last modified on | 2016/08/20 10:05:23 |
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Basic information
Public title
Chronic kidney disease-A Prospective study of Treatment for Renal Anemia on Prognosis in hemodialysis patients study.
Acronym
CKD-TRAP study
Scientific Title
Chronic kidney disease-A Prospective study of Treatment for Renal Anemia on Prognosis in hemodialysis patients study.
Scientific Title:Acronym
CKD-TRAP study
Region
| Japan |
Condition
Condition
Chronic Kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Estimation of the effect of nutritional state, inflammation, anemia, and the treatment on the renal function and cardiovascular disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Kidney function
2) Adverse event (Cardiovascular disease, infectious disease, death)
Key secondary outcomes
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with CKD stage 3-5.
Key exclusion criteria
Patients with chronic inflammation or malignant disease.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kuragano Takahiro |
Organization
Hyogo College of Medicine
Division name
Department of Internal Medicine
Zip code
Address
1-1, Mukogawa Cho, Nisinomiya, Hyogo
TEL
0798-45-6521
kuragano@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kuragano Takahiro |
Organization
Hyogo College of Medicine
Division name
Department of Internal Medicine
Zip code
Address
1-1, Mukogawa Cho, Nisinomiya, Hyogo
TEL
0798-45-6521
Homepage URL
kuragano@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
兵庫医科大学、埼玉医科大学医療センター、香川医科大学、熊本大学、福岡大学、宮崎大学、東邦医科大学
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Estimation of the relationship between the treatment and renal function, adverse event in chronic kidney disease.
Management information
Registered date
| 2012 | Year | 12 | Month | 03 | Day |
Last modified on
| 2016 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011121
