UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Chronic kidney disease-A Prospective study of Treatment for Renal Anemia on Prognosis in hemodialysis patients study.
Title of the study (Brief title)	CKD-TRAP study
Region	Japan

Condition
Condition	Chronic Kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Estimation of the effect of nutritional state, inflammation, anemia, and the treatment on the renal function and cardiovascular disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Kidney function 2) Adverse event (Cardiovascular disease, infectious disease, death)
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with CKD stage 3-5.
Key exclusion criteria	Patients with chronic inflammation or malignant disease.
Target sample size	1000

Research contact person
Name of lead principal investigator	Kuragano Takahiro
Organization	Hyogo College of Medicine
Division name	Department of Internal Medicine
Address	1-1, Mukogawa Cho, Nisinomiya, Hyogo
TEL	0798-45-6521
Email	kuragano@hyo-med.ac.jp

Public contact
Name of contact person	Kuragano Takahiro
Organization	Hyogo College of Medicine
Division name	Department of Internal Medicine
Address	1-1, Mukogawa Cho, Nisinomiya, Hyogo
TEL	0798-45-6521
Homepage URL
Email	kuragano@hyo-med.ac.jp

Sponsor
Institute	Hyogo college of Medicine
Institute
Department

Funding Source
Organization	None
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	兵庫医科大学、埼玉医科大学医療センター、香川医科大学、熊本大学、福岡大学、宮崎大学、東邦医科大学

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 10 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 12 Month 01 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date	2017 Year 12 Month 01 Day
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	Estimation of the relationship between the treatment and renal function, adverse event in chronic kidney disease.

Management information
Registered date	2012 Year 12 Month 03 Day
Last modified on	2016 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011121