UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of epoetin beta pegol treatment on renal anemia and blood pressure control in non-dialytic CKD patients
Title of the study (Brief title)	Effect of epoetin beta pegol on renal anemia and blood pressure in non-dialytic CKD patients
Region	Japan

Condition
Condition	non-dyalitic chronic kidney disease (CKD)
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify effect of epoetin beta pegol injection on blood Hb level and mean blood pressure as well as its fluctuation during outpatient clinic in non-dialytic patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood Hb level before and after epoetin beta pegol treatment and mean blood pressure as well as its fluctuation during outpatient clinic.
Key secondary outcomes	Correlation between blood pressure fluctuation and incidence of cardiovascular events before and after epoetin beta pegol treatment.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Epoetin beta pegol injection to treat renal anemia
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Chronic kidney disease stage 4 and 5, non-dialytic 2. Hb level lower than 11g/dl 3. Longer than 6 months of therapeutic period estimated until initiation of dialysis 4. Volantary consent obtained after adequate explanation on the study
Key exclusion criteria	1. Allergic to erythropoiesis stimulating agents (ESA) 2. Either malignant diseases, severe infectious diseases, or significant adverse conditions complicated 3. Other inadequate occasions assessed by the attending physician
Target sample size	100

Research contact person
Name of lead principal investigator	Kenichiro Asano
Organization	Kurashiki Central Hospital
Division name	Nephrology
Address	1-1-1 Miwa Kurashiki-city Okayama 710-8602 Japan
TEL	086-422-0210
Email

Public contact
Name of contact person	Kenichiro Asano
Organization	Kurashiki Central Hospital
Division name	Nephrology
Address	1-1-1 Miwa Kurashiki-city Okayama 710-8602 Japan
TEL	086-422-0210
Homepage URL	http://kchsps1/SiteDirectory/d3750/SitePages/Home.aspx
Email	ka11734@kchnet.or.jp

Sponsor
Institute	Kurashiki Central Hospital
Institute
Department

Funding Source
Organization	Kurashiki Central Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	倉敷中央病院　　Kurashiki Central Hospital

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 01 Day
Anticipated trial start date	2013 Year 01 Month 04 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2015 Year 12 Month 31 Day
Date trial data considered complete	2015 Year 12 Month 31 Day
Date analysis concluded	2018 Year 01 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 12 Month 01 Day
Last modified on	2018 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011080