UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000011256