UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between variability of iron-related parameters under iron supplementation and prognosis in hemodialysis patients with renal anemia
Acronym	The relationship between variability of iron-related parameters under iron supplementation and prognosis in hemodialysis patients with renal anemia
Scientific Title	The relationship between variability of iron-related parameters under iron supplementation and prognosis in hemodialysis patients with renal anemia
Scientific Title:Acronym	The relationship between variability of iron-related parameters under iron supplementation and prognosis in hemodialysis patients with renal anemia
Region	Japan

Condition
Condition	end stage renal disease
Classification by specialty	Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will investigate that relationship between iron-related parameters and prognosis in hemodialysis patients.
Basic objectives2	Others
Basic objectives -Others	(1) Blood cell examination (2) Blood chemical examination including iron-related, inflammation, nutrition indexes (3) Hemodynamic parameters
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Death and its reason in five years.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Patients with maintenance hemodialysis (2) Patients with renal anemia, who are treated with rHuEPO and iron
Key exclusion criteria	Severe congestive heart failure Uncontrolled hypertension Malignancy Major surgery within the previous 6 months Active bleeding, need for erythrocyte transfusion within 12 weeks before the study Systemic inflammatory disease and/or C-reactive protein levels >3 mg/dL
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tetsuya Fujikawa
Organization	Yokohama National University
Division name	Center for Health Service Sciences
Zip code
Address	79-8 Tokiwa-dai, Hodogaya-ku, Yokohama city, Japan.
TEL	045-339-3153
Email	tftf@ynu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tetsuya Fujikawa
Organization	Yokohama National University
Division name	Center for Health Service Sciences
Zip code
Address	79-8 Tokiwa-dai, Hodogaya-ku, Yokohama city, Jap
TEL	045-339-3153
Homepage URL
Email	tftf@ynu.ac.jp

Sponsor
Institute	Yokodai Central Clinic
Institute
Department

Funding Source
Organization	Yokodai Central Clinic
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 23 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 01 Day
Date of IRB	2017 Year 08 Month 09 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2018 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective cohort study

Management information
Registered date	2017 Year 02 Month 23 Day
Last modified on	2020 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030174