UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of iron dosing according to iron demand in hemodialysis patients treated with Darbepoetin alfa
Title of the study (Brief title)	Evaluation of iron dosing according to iron demand in hemodialysis patients treated with Darbepoetin alfa
Region	Japan

Condition
Condition	Patients treated with maintenance hemodialysis
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of iron supplementation on Darbepoetin alfa efficacy
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 Darbepoetin alfa (4)Hemodynamic parameters
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
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 after Darbepoetin alfa administration (Fesin 10mg x 3 in a week)
Interventions/Control_2	No iron supplementation
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	100

Research contact person
Name of lead principal investigator	Tadashi Kuji
Organization	Yokodai Central Clinic
Division name	Director /Director of hemodialysis clinic
Address	3-9-31 Yokodai, Isogo-ku, Yokohama city, Japan
TEL	045-830-5511
Email	t.kuji@houshinkai.or.jp

Public contact
Name of contact person	Tadashi Kuji
Organization	Yokodai Central Clinic
Division name	Director /Director of hemodialysis clinic
Address	3-9-31 Yokodai, Isogo-ku, Yokohama city, Japan
TEL	045-830-5511
Homepage URL
Email	t.kuji@houshinkai.or.jp

Sponsor
Institute	Yokodai Central Clinic
Institute
Department

Funding Source
Organization	Houshin-kai medical corporation, Yokodai Central 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	朋進会透析クリニック(神奈川県)

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 15 Day
Anticipated trial start date	2014 Year 12 Month 08 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 07 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=R000018465