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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029335
Receipt No. 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

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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
Email 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
Email irb_cent@yahoo.co.jp

Sponsor
Institute Tsukuba Central Hospital
Institute
Department

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
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 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
URL(English) https://upload.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


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