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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006813
Receipt No. 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

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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
Institute Niigata University
Institute
Department

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
URL(English) https://upload.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


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