UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019283
Receipt number R000022296
Scientific Title Low dose iron supplementation and efficacy of erythropoiesis in renal anemia treatment for hemodialysis patients: a randomized controlled study
Date of disclosure of the study information 2015/10/08
Last modified on 2018/04/10 10:40:22

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Basic information

Public title

Low dose iron supplementation and efficacy of erythropoiesis in renal anemia treatment for hemodialysis patients: a randomized controlled study

Acronym

Low dose iron supplementation and efficacy of erythropoiesis induced by epoetin beta pegol

Scientific Title

Low dose iron supplementation and efficacy of erythropoiesis in renal anemia treatment for hemodialysis patients: a randomized controlled study

Scientific Title:Acronym

Low dose iron supplementation and efficacy of erythropoiesis induced by epoetin beta pegol

Region

Japan


Condition

Condition

Renal anemia

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of epoetin beta pegol efficacy between low dose iron and routine iron supplementations.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

(1) Hemoglobin and erythropoiesis-related indexes
(2)Blood chemical examination including iron-related, inflammation, nutrition indexes
(3)Required dose of epoetin beta pegol
(4)Hemodynamic parameters

(After 3 months of iron supplementation)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Low dose iron supplementation (Fesin 6A/ 3months)

Interventions/Control_2

Routine iron supplementation (Fesin 12A/ 3months)

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

(1) Patients with chronic inflammation, malignant disorder, severe congestive heart failure, respiratory organs, and liver disorder
(2) Patients who are receiving dialysis modalities other than hemodialysis

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomoyuki Kawano

Organization

Bunko Jin Clinic

Division name

Director /Director of hemodialysis clinic

Zip code


Address

35 Yatsuchou, Kanazawa-ku, Yokohama city, Japan

TEL

045-790-8280

Email

t-kawano@kousai.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoyuki Kawano

Organization

Bunko Jin Clinic

Division name

Director /Director of hemodialysis clinic

Zip code


Address

35 Yatsuchou, Kanazawa-ku, Yokohama city, Japan

TEL

045-790-8280

Homepage URL


Email

t-kawano@kousai.or.jp


Sponsor or person

Institute

Bunko Jin Clinic

Institute

Department

Personal name



Funding Source

Organization

Kousai-kai medical corporation, Bunko Jin Clinic

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

厚済会透析クリニック(神奈川県)


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 08 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

2015 Year 08 Month 29 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 08 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 10 Month 08 Day

Last modified on

2018 Year 04 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022296


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name