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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017032
Receipt No. R000019753
Scientific Title Association between serum zinc consentrations and renal anemia in patients with hemodialysis
Date of disclosure of the study information 2015/04/03
Last modified on 2017/01/18

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Basic information
Public title Association between serum zinc consentrations and renal anemia in patients with hemodialysis
Acronym Association of zinc and anemia
Scientific Title Association between serum zinc consentrations and renal anemia in patients with hemodialysis
Scientific Title:Acronym Association of zinc and anemia
Region
Japan

Condition
Condition Renal anemia
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of zinc supplementation for renal anemia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes hemoglobin concentration, Dose of erythropoiesis stimulating agent(ESA), ESA responsiveness index
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral zinc supplementation
Interventions/Control_2 Control
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) age more than 20 years or less than 85 years, (2) on hemodialysis for at least 6 months, and (3) zinc deficiency defined as a serum zinc level < 65 micro g/dl
Key exclusion criteria (1) age of < 20 years or > 85 years; (2) recent infectious disease, cancer, or drug/alcohol abuse; (3) treatment with steroids or immunosuppressants; (4) currently hospitalized; (5) previous history of blood transfusion for at least 6 months before the study; or (6) recent hospitalization or unwillingness to participate in the study.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Abe
Organization Nihon University School of Medicine
Division name Nephrology, Hypertension and Endocrinology
Zip code
Address 30-1, Oyaguchi Kami-chou, Itabshi-ku, Tokyo, Japan
TEL 03-3972-8111
Email mabe@med.nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Abe
Organization Nihon University School of Medicine
Division name Nephrology, Hypertension and Endocrinology
Zip code
Address 30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo, 173-8610, Japan
TEL 03-3972-8111
Homepage URL
Email mabe@med.nihon-u.ac.jp

Sponsor
Institute Keiai Hospital
Institute
Department

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
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
2015 Year 04 Month 03 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 Completed
Date of protocol fixation
2012 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 01 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

Management information
Registered date
2015 Year 04 Month 03 Day
Last modified on
2017 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019753

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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