UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017032
Receipt number 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 14:21:02

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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 or person

Institute

Keiai Hospital

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


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

Value
https://center6.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