UMIN-CTR Clinical Trial

Basic information
Public title	The effect of Darbepoetin for renal anemia and iron kinetics in Chronic Kidney Disease(CKD) patients
Acronym	The effect of Darbepoetin for renal anemia and iron kinetics in Chronic Kidney Disease(CKD) patients
Scientific Title	The effect of Darbepoetin for renal anemia and iron kinetics in Chronic Kidney Disease(CKD) patients
Scientific Title:Acronym	The effect of Darbepoetin for renal anemia and iron kinetics in Chronic Kidney Disease(CKD) patients
Region	Japan

Condition
Condition	Chronic kidney disease and renal anemia
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effect of Darbepoetin for renal anemia in CKD patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The mean hemoglobin(Hb) change and the achievement rate of Hb target concentration
Key secondary outcomes	Iron kinetics

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Epoetin
Interventions/Control_2	Darbepoetin
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	The concentration of Hb is under 11.0mg/dl in CKD patients
Key exclusion criteria	severe heart failure impossible control of hypertension and so on
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takayasu Ito
Organization	Yamamoto General Hospital
Division name	Internal Medicine
Zip code
Address	3-11 Kotobuki-cho Kuwana city Mie prefecture
TEL	059221211
Email	takayassu@msn.com

Public contact
Name of contact person	1st name Middle name Last name Takayasu Ito
Organization	Yamamoto general hospital
Division name	Internal Medicine
Zip code
Address	3-11 Kotobuki-cho Kuwana city Mie prefecture
TEL	0594221211
Homepage URL
Email	takayassu@msn.com

Sponsor
Institute	Yamamoto General Hospital
Institute
Department

Funding Source
Organization	Yamamoto General Hospital
Organization
Division
Category of Funding Organization	Self funding
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	2011 Year 02 Month 10 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	Terminated
Date of protocol fixation	2010 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date	2010 Year 02 Month 01 Day
Last follow-up date	2012 Year 03 Month 31 Day
Date of closure to data entry	2012 Year 03 Month 31 Day
Date trial data considered complete	2012 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 02 Month 10 Day
Last modified on	2014 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006025

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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