UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006813
Receipt number R000007917
Scientific Title Determination of switching dose from preexisting ESAs to epoetin beta pegol in peritoneal dialysis patients.
Date of disclosure of the study information 2011/12/12
Last modified on 2013/12/20 14:03:11

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Basic information

Public title

Determination of switching dose from preexisting ESAs to epoetin beta pegol in peritoneal dialysis patients.

Acronym

Determination of efficacy of epoetin beta pegol in peritoneal dialysis patients

Scientific Title

Determination of switching dose from preexisting ESAs to epoetin beta pegol in peritoneal dialysis patients.

Scientific Title:Acronym

Determination of efficacy of epoetin beta pegol in peritoneal dialysis patients

Region

Japan


Condition

Condition

Anemia with chronic kidney disease

Classification by specialty

Medicine in general Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Improvement of renal survival

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Kidney survival rate

Key secondary outcomes

Target achievement rate of anemia correction


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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

anemia with chronic kidney disease
20 years old or more
Written consent of study participation

Key exclusion criteria

The case whom physician think that the patient should not participate in this study.
A patient who has cancer.
A patient who has active gastrointestinal bleeding.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ichiei Narita

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Clinical Nephrology and Rheumatology

Zip code


Address

1-757 Asahimachi-dori, Niigata 951-8510 JAPAN

TEL

025-227-2200

Email

naritai@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriaki Iino

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Clinical Nephrology and Rheumatology

Zip code


Address

1-757 Asahimachi-dori, Niigata 951-8510 JAPAN

TEL

025-227-2200

Homepage URL


Email

niino@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University

Institute

Department

Personal name



Funding Source

Organization

Niigata University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN


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

新潟大学医歯学総合病院(新潟県)、長岡赤十字病院(新潟県)、長岡中央病院(新潟県)、新潟県立中央病院(新潟県)、新潟県立新発田病院【新潟県】


Other administrative information

Date of disclosure of the study information

2011 Year 12 Month 12 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

2011 Year 11 Month 24 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

2013 Year 12 Month 01 Day

Date of closure to data entry

2013 Year 12 Month 01 Day

Date trial data considered complete

2013 Year 12 Month 01 Day

Date analysis concluded

2014 Year 04 Month 01 Day


Other

Other related information

Determination of switching dose of epoetin-beta pegol from darbepoetin alfa in patients undergoing peritoneal dialysis.
Target achievement of anemia correction in patients undergoing peritoneal dialysis.


Management information

Registered date

2011 Year 12 Month 01 Day

Last modified on

2013 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007917


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name