UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009658
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Saiseikai yokohama-city tobu hospital
Institute
Department

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
URL(English) https://upload.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


Contact us.