UMIN-CTR Clinical Trial

Basic information
Public title	Clinical assessment of serum hepcidin isoforms associated with iron homeostasis and erythropoiesis-stimulating agent response in CKD patients
Acronym	Clinical assessment of serum hepcidin isoforms associated with iron homeostasis and erythropoiesis-stimulating agent response in CKD patients
Scientific Title	Clinical assessment of serum hepcidin isoforms associated with iron homeostasis and erythropoiesis-stimulating agent response in CKD patients
Scientific Title:Acronym	Clinical assessment of serum hepcidin isoforms associated with iron homeostasis and erythropoiesis-stimulating agent response in CKD patients
Region	Japan

Condition
Condition	CKD
Classification by specialty	Hematology and clinical oncology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the association of serum hepcidin, iron-related biomarker, erythropoitic activity and cytokine, and to asses erythropoiesis-stimulating agent response in CKD patients
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The relationship between the change of serum hepcidin and the responsiveness to erythropoiesis-stimulating agent
Key secondary outcomes	To evaluate the association of serum hepcidin, iron-related biomarker, erythropoitic activity and serum cytokine

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	The enrolled patients who have been diagnosed as CKD.
Key exclusion criteria	These patients were excluded with severe inflammatory disease, infection, cancer, hematological disorders or blood transfusion within 4 weeks.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuhito Takeda
Organization	Iizuka Hospital
Division name	The department of nephrology
Zip code
Address	Yoshiomachi 3-83,Iizuka,Fukuoka,Japan
TEL	0948-22-3800
Email

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Kimura
Organization	Iizuka Hospital
Division name	The department of nephrology
Zip code
Address	Yoshiomachi 3-83,Iizuka,Fukuoka,Japan
TEL	0948-22-3800
Homepage URL
Email	hkimurah2@aih-net.com

Sponsor
Institute	iizuka Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	1) Kamakura Research Laboratory of Chugai Pharmaceutical CO., LTD.
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	飯塚病院（福岡県）

Other administrative information
Date of disclosure of the study information	2010 Year 04 Month 01 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	2008 Year 09 Month 01 Day
Date of IRB	2008 Year 07 Month 21 Day
Anticipated trial start date	2008 Year 09 Month 01 Day
Last follow-up date	2013 Year 12 Month 01 Day
Date of closure to data entry	2014 Year 03 Month 01 Day
Date trial data considered complete	2014 Year 03 Month 01 Day
Date analysis concluded	2014 Year 06 Month 01 Day

Other
Other related information	Blood samples for whole blood and serum parameters were obtained at the start of the study and would be obtained in the next 3, 6, 12, 24 months time.

Management information
Registered date	2010 Year 04 Month 01 Day
Last modified on	2019 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004150