UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between serum zinc consentrations and renal anemia in patients with hemodialysis
Title of the study (Brief title)	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	Masanori Abe
Organization	Nihon University School of Medicine
Division name	Nephrology, Hypertension and Endocrinology
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	Masanori Abe
Organization	Nihon University School of Medicine
Division name	Nephrology, Hypertension and Endocrinology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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