UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease
Title of the study (Brief title)	Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease
Region	Japan

Condition
Condition	Renal anemia in chronic kidney disease
Classification by specialty	Medicine in general Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the response to rHuEPO or epoetin beta pegol for the treatment of renal anemia in patients with chronic kidney disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	(1)Comparison of changes in hepcidin concentrations between patients treated with rHuEPO or those treated with epoetin beta pegol (2)Identification of factors affecting the treatment response to rHuEPO or epoetin beta pegol
Key secondary outcomes	(1)Effects of rHuEPO and epoetin beta pegol on iron metabolism (2)Changes in dosage of epoetin beta pegol and Hb level

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	CERA Group: Epoetin beta pegol is subcutaneously administered once every two weeks.
Interventions/Control_2	rHuEPO Group: rHuEPO is subcutaneously administered once every two weeks.
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)Patients with no prior treatment with ESA (2)Patients 20 years old or older at time of study initiation (3)Patients with a hemoglobin (Hb) level of >= 8 g/dL and < 11 g/dL (4)Patients with eGFR of < 60 mL/min/1.73m2 (5)Patients who give written informed consent
Key exclusion criteria	(1)Patients on hemodialysis or peritoneal dialysis (2)Patients who underwent renal transplant (3)Patients with malignancy or hematological diseases (such as MDS) (4)Patients with severe complications, such as severe infections (5)Patients who take iron therapy (6)Patients who are judged to be ineligible by an attending doctor
Target sample size	40

Research contact person
Name of lead principal investigator	Koji Mitsuiki
Organization	Fukuoka Red Cross Hospital
Division name	Division of Nephrology
Address	3-1-1 Ohgusu, Minami-ku, Fukuoka
TEL	092-551-1211
Email	koji@fukuoka-med.jrc.or.jp

Public contact
Name of contact person	Koji Mitsuiki
Organization	Fukuoka Red Cross Hospital
Division name	Division of Nephrology
Address	3-1-1 Ohgusu, Minami-ku, Fukuoka
TEL	092-551-1211
Homepage URL
Email	koji@fukuoka-med.jrc.or.jp

Sponsor
Institute	Fukuoka Red Cross Hospital
Institute
Department

Funding Source
Organization	Fukuoka Red Cross Hospital, Kyushu University
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	福岡赤十字病院（福岡県）,九州大学（福岡県）,宗像医師会病院（福岡県）,九州医療センター（福岡県）,原三信病院（福岡県）,福岡東医療センター（福岡県）,浜の町病院（福岡県）,白十字病院（福岡県）,小倉記念病院（福岡県）,飯塚病院（福岡県）,掖済会門司病院（福岡県）,製鉄記念八幡病院（福岡県）,聖マリア病院（福岡県）

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 04 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 05 Month 18 Day
Anticipated trial start date	2012 Year 12 Month 05 Day
Last follow-up date	2016 Year 06 Month 03 Day
Date of closure to data entry	2016 Year 06 Month 03 Day
Date trial data considered complete	2016 Year 06 Month 03 Day
Date analysis concluded	2017 Year 12 Month 07 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 03 Day
Last modified on	2017 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011078