UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009658
Receipt number R000011256
Scientific Title A study of the hematopoietic and iron metabolism effect of epoetin beta pegol on non-dialysis chronic kidney disease patients who do not respond well to darbepoetin alfa by monitoring hepcidin-25.
Date of disclosure of the study information 2013/02/01
Last modified on 2020/01/03 10:01:55

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Basic information

Public title

A study of the hematopoietic and iron metabolism effect of epoetin beta pegol on non-dialysis chronic kidney disease patients who do not respond well to darbepoetin alfa by monitoring hepcidin-25.

Acronym

A study of the hematopoietic and iron metabolism effect of epoetin beta pegol on non-dialysis chronic kidney disease patients who do not respond well to darbepoetin alfa by monitoring hepcidin-25.

Scientific Title

A study of the hematopoietic and iron metabolism effect of epoetin beta pegol on non-dialysis chronic kidney disease patients who do not respond well to darbepoetin alfa by monitoring hepcidin-25.

Scientific Title:Acronym

A study of the hematopoietic and iron metabolism effect of epoetin beta pegol on non-dialysis chronic kidney disease patients who do not respond well to darbepoetin alfa by monitoring hepcidin-25.

Region

Japan


Condition

Condition

non-dialysis chronic kidney disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The main objective of this study is to estimate the hematopoietic and iron metabolism effect of epoetin beta pegol on non-dialysis chronic kidney disease patients who do not respond well to darbepotin alfa by monitoring hepcidin-25 on a randomaized controlled trial.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Percentage of maintaining the target Hb level

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

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

darbepoetin alfa

Interventions/Control_2

epoetin beta pegol

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients of filling the following all criteria and having ability for agreement

1)The patients diagnosed of renal anemia ,administrated darbepoetin alfa for more than six months and less than 11g/dl hemoglobin.

Key exclusion criteria

the patients having allergy for epoetin beta pegol ,erythropoietin and darbepoetin alfa

the patients of gastrointestinal hemorrhage

the patients having or had liver damages

Target sample size

40


Research contact person

Name of lead principal investigator

1st name kiyoto
Middle name
Last name koibuchi

Organization

Saiseikai yokohama-city tobu hospital

Division name

nephrology

Zip code

230-0012

Address

3-6-1 shimosueyoshi tsurumi-ku yokohama city kanagawa

TEL

045-576-3000

Email

k_koibuchi@tobu.saiseikai.or.jp


Public contact

Name of contact person

1st name kiyoto
Middle name
Last name koibuchi

Organization

Saiseikai yokohama-city tobu hospital

Division name

nephrology

Zip code

230-0012

Address

3-6-1 shimosueyoshi tsurumi-ku yokohama city kanagawa

TEL

045-576-3000

Homepage URL


Email

buchi500@msn.com


Sponsor or person

Institute

Saiseikai yokohama-city tobu hospital

Institute

Department

Personal name



Funding Source

Organization

The Kidney Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

japan


Other related organizations

Co-sponsor

saiseikai kanagawaken hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Saiseikai Yokohama city tobu hospital

Address

3-6-1 shimosueyoshi tsurumi yokohama

Tel

045-576-3000

Email

k_koibuchi@tobu.saiseikai.or.jp


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

済生会横浜市東部病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2013 Year 02 Month 01 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000011256

Publication of results

Unpublished


Result

URL related to results and publications

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000011256

Number of participants that the trial has enrolled

24

Results

anemia

Results date posted

2020 Year 01 Month 03 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

CKD

Participant flow

none

Adverse events

none

Outcome measures

hemoglobin

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

2013 Year 01 Month 20 Day

Anticipated trial start date

2013 Year 02 Month 01 Day

Last follow-up date

2015 Year 01 Month 31 Day

Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete

2015 Year 03 Month 31 Day

Date analysis concluded

2019 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2012 Year 12 Month 28 Day

Last modified on

2020 Year 01 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011256


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name