UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Iron supplementation timing and efficacy of erythropoiesis in hemodialysis patients receiving epoetin beta pegol: a randomized controlled study
Title of the study (Brief title)	Iron supplementation timing and efficacy of erythropoiesis in hemodialysis patients receiving epoetin beta pegol
Region	Japan

Condition
Condition	Renal anemia
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of epoetin beta pegol efficacy between different timed iron supplementations.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) Hemoglobin and erythropoiesis-related indexes (2)Blood chemical examination including iron-related, inflammation, nutrition indexes (3)Required dose of epoetin beta pegol (4)Hemodynamic parameters (5)Prognosis
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Iron supplementation following epoetin beta pegol administration
Interventions/Control_2	Iron supplementation two weeks after epoetin beta pegol administration
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 maintenance hemodialysis (2) Patients with renal anemia, who are treated with rHuEPO or iron
Key exclusion criteria	(1) Patients with chronic inflammation, malignant disorder, severe congestive heart failure, respiratory organs, and liver disorder (2) Patients who are receiving dialysis modalities other than hemodialysis
Target sample size	200

Research contact person
Name of lead principal investigator	Tomoyuki Kawano
Organization	Bunko Jin Clinic
Division name	Director /Director of hemodialysis clinic
Address	35 Yatsuchou, Kanazawa-ku, Yokohama city, Japan
TEL	045-790-8280
Email	t-kawano@kousai.or.jp

Public contact
Name of contact person	Tomoyuki Kawano
Organization	Bunko Jin Clinic
Division name	Director /Director of hemodialysis clinic
Address	35 Yatsuchou, Kanazawa-ku, Yokohama city, Japan
TEL	045-790-8280
Homepage URL
Email	t-kawano@kousai.or.jp

Sponsor
Institute	Bunko Jin Clinic
Institute
Department

Funding Source
Organization	Kousai-kai medical corporation, Bunko Jin Clinic
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	厚済会透析クリニック(神奈川県)

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 25 Day
Anticipated trial start date	2015 Year 01 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2015 Year 01 Month 29 Day
Last modified on	2017 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019015