UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective Study of Treatment for Renal Anemia on Prognosis in Hemodialysis Patients
Title of the study (Brief title)	TRAP study
Region	Japan

Condition
Condition	Patients with renal anemia receiving erythropoietin, who have maintained dialysis therapy for over 1 year
Classification by specialty	Nephrology Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The object of this study is to clarify the effects of the doses of erythropoietin and iron on the nutritional state, cardiovascular events,hospitalization and mortality in the treatment for renal anemia.
Basic objectives2	Others
Basic objectives -Others	Testing the relationship between the parameters regarding iron metabolism and survival rate in the patients who have been treated for renal anemia.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Doses of erythropoietin and iron requiring for the maintaince of Hb level>11 g/dl 2) Nutritional state 3) Cardiovascular event 4) Hospitaization 5) Survival rate
Key secondary outcomes	The relationships among Hb, ferritin level and markers of nutritional state (TP, albumin, pre-albumin, T-CHO, H-CHO, TG), and cardiovascular risk factors (MDA, MPO, Hs-CRP, TnT)

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	18 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with renal anemia receiving erythropoietin, who have maintained dialysis therapy for over 1 year.
Key exclusion criteria	Patients with malignancy, infection or inflammatory diseases.
Target sample size	500

Research contact person
Name of lead principal investigator	Takeshi Nakanishi
Organization	Hyogo College of Medicine
Division name	Internal Medicine Division of Nephrology and Dialysis
Address	1-1 Mukogawa cho, Nishinomiya, Japan
TEL	0798-45-6521
Email	jin@hyo-med.ac.jp

Public contact
Name of contact person	Takahiro Kuragano
Organization	Hyogo College of Medicine
Division name	Internal Medicine Division of Nephrology and Dialysis
Address	1-1 Mukogawa cho, Nishinomiya, Japan
TEL	0798-45-6521
Homepage URL
Email	kuragano@hyo-med.ac.jp

Sponsor
Institute	TRAP study office
Institute
Department

Funding Source
Organization	Department account fund
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

Other administrative information
Date of disclosure of the study information	2007 Year 06 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2007 Year 04 Month 01 Day
Anticipated trial start date	2007 Year 05 Month 01 Day
Last follow-up date	2010 Year 06 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	A prosopective clinical study

Management information
Registered date	2007 Year 04 Month 19 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=R000000822