UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026276
Receipt number R000030174
Scientific Title The relationship between variability of iron-related parameters under iron supplementation and prognosis in hemodialysis patients with renal anemia
Date of disclosure of the study information 2017/02/23
Last modified on 2020/08/27 12:51:53

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Basic information

Public title

The relationship between variability of iron-related parameters under iron supplementation and prognosis in hemodialysis patients with renal anemia

Acronym

The relationship between variability of iron-related parameters under iron supplementation and prognosis in hemodialysis patients with renal anemia

Scientific Title

The relationship between variability of iron-related parameters under iron supplementation and prognosis in hemodialysis patients with renal anemia

Scientific Title:Acronym

The relationship between variability of iron-related parameters under iron supplementation and prognosis in hemodialysis patients with renal anemia

Region

Japan


Condition

Condition

end stage renal disease

Classification by specialty

Cardiology Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will investigate that relationship between iron-related parameters and prognosis in hemodialysis patients.

Basic objectives2

Others

Basic objectives -Others

(1) Blood cell examination
(2) Blood chemical examination including iron-related, inflammation, nutrition indexes
(3) Hemodynamic parameters

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Death and its reason in five years.

Key secondary outcomes



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

(1) Patients with maintenance hemodialysis
(2) Patients with renal anemia, who are treated with rHuEPO and iron

Key exclusion criteria

Severe congestive heart failure
Uncontrolled hypertension
Malignancy
Major surgery within the previous 6 months
Active bleeding, need for erythrocyte transfusion within 12 weeks before the study
Systemic inflammatory disease and/or C-reactive protein levels >3 mg/dL

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya Fujikawa

Organization

Yokohama National University

Division name

Center for Health Service Sciences

Zip code


Address

79-8 Tokiwa-dai, Hodogaya-ku, Yokohama city, Japan.

TEL

045-339-3153

Email

tftf@ynu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuya Fujikawa

Organization

Yokohama National University

Division name

Center for Health Service Sciences

Zip code


Address

79-8 Tokiwa-dai, Hodogaya-ku, Yokohama city, Jap

TEL

045-339-3153

Homepage URL


Email

tftf@ynu.ac.jp


Sponsor or person

Institute

Yokodai Central Clinic

Institute

Department

Personal name



Funding Source

Organization

Yokodai Central Clinic

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



Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 23 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

2016 Year 01 Month 01 Day

Date of IRB

2017 Year 08 Month 09 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2018 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective cohort study


Management information

Registered date

2017 Year 02 Month 23 Day

Last modified on

2020 Year 08 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030174


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name