UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029335 |
|---|---|
| Receipt number | R000033462 |
| Scientific Title | Erythropoietin Production in Chronic Kidney Disease |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2018/09/03 19:27:55 |
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Basic information
Public title
Erythropoietin Production in Chronic Kidney Disease
Acronym
EPO production in CKD
Scientific Title
Erythropoietin Production in Chronic Kidney Disease
Scientific Title:Acronym
EPO production in CKD
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Chronic Renal Failure
Renal Anemia
Classification by specialty
| Hematology and clinical oncology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation for extra-renal production of erythropoietin in patients with chronic kidney disease
Basic objectives2
Others
Basic objectives -Others
Observation study for unknown pathophysiological mechanism
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Erythropoietin isozyme
Key secondary outcomes
Erythropoietin concentration, Peripheral blood study (RBC count, WBC count, hemoglobin, hematocrit, platelet count, reticulocyte count, WBC fraction), Biochemical study(total protein, albumin, blood urea nitrogen, creatinine, urea, Na, K, Cl, Ca, P, CRP, Fe, Ferritin, TIBC), oxidative stress markers
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
CKD patients under observation at Tsukuba Central Hospital, Central Jin Clinic Ryugasaki, Central Sougou Clinic and Center for Integrative Medicine, Tsukuba University of Technology.
Key exclusion criteria
1. Patients who are assessed as unsuitable for research by a research responsible doctor or research sharing doctor
2. Patients who are willing to refuse to participate in the study
3. Patients who are under the age of 20, or who can not express self-will
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yanagawa, Takamoto |
Organization
Tsukuba Central Hospital
Division name
Department of Nephrology
Zip code
Address
1589-3 Kashiwada-cho Ushiku, Ibaraki, Japan
TEL
029-872-1771
irb_cent@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yanagawa, Takamoto |
Organization
Tsukuba Central Hospital
Division name
Department of Nephrology
Zip code
Address
1589-3 Kashiwada-cho Ushiku, Ibaraki, Japan
TEL
029-872-1771
Homepage URL
irb_cent@yahoo.co.jp
Sponsor or person
Institute
Tsukuba Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsukuba University of Technology
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
つくばセントラル病院(茨城県)，セントラル腎クリニック龍ヶ崎(茨城県)，セントラル総合クリニック(茨城県)，筑波技術大学東西医学統合医療センター(茨城県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims too identify the mechanism of extra-renal erythrocyte production and contribulte to prevent the progress of renal anemia and lead a new drug discovery.
Management information
Registered date
| 2017 | Year | 09 | Month | 28 | Day |
Last modified on
| 2018 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033462
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
