UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of erythropoietin beta pegol assessment study with kidney diseases.
Title of the study (Brief title)	EPACME Study (ErythroPoietin Assessment in CKD patients by Metabolic and Endocrinological factors)
Region	Japan

Condition
Condition	renal anemia
Classification by specialty	Medicine in general Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of epoetin beta pegol on renal anemia.
Basic objectives2	Others
Basic objectives -Others	To evaluate the effect of epoetin beta pegol on renal function, cardiac function, lipid and oxidative stress.
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Percentage of maintaining the target Hb (over 11.0 g/dL)
Key secondary outcomes	1. urinary 8-OHdG, small dense LDL, small dense LDL/LDL-C, oxidizedLDL, blood pressure, pulse rate, antihypertensive drugs, diuretics, antihyperlipidemic drugs, type of iron, dose of iron (0,2,12 month). 2. T-Cho, TG, HDL-C, LDL-C, LDL-C/HDL-C, eGFR, BNP (0,2,4,6,8,10,12 month) 3. Safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Epoetin beta pegol 25-250 microg/2-8 weeks
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 renal anemiaa 2. patients with CKD stage 3-5 3. patients without dialysis 4. patients without renal transplantation 5. outpatient 6. patients with informed consent 7. patients are enrolled on trial with two groups (non-diabetic and diabetic groups)
Key exclusion criteria	1. patients with uncontrolled hypertension (SBP >=180mmHg, DBP >= 110mmHg) 2. patients with critical cardiac and/or vascular complications 3. patients whose Hb level must be maintained less than 12.0 g/dL 4. patients who needs blood transfusion 5. patients with anemia other than renal anemia 6. patients with liver dysfunction [GPT(ALT) over three times the normal value] 7. patients with malignancies under current treatment 8. pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period 9. patients with uncontrolled arrhythmia 10. patients with cardiac insufficiency (NYHA grade III or IV) 11. patients with a history of hypersensitivity to ingredients of epoetin alpha, epoetin beta, darbopoetin alpha 13. patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size	100

Research contact person
Name of lead principal investigator	Hideki Yokoi
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Nephrology
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 6068507, Japan
TEL	075-751-4420
Email	yokoih@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Hideki Yokoi
Organization	Kyoto Univesity Graduate School of Medicne
Division name	Department of Nephrology
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 6068507, Japan
TEL	075-751-4420
Homepage URL
Email	yokoih@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Osaka Redcross,Hirakata Kohsai, Saiseikai Ibaraki, Kyoto Medical Center, National Cerebral and Cardiovascular Center, Kobe Medical Center General, NTT west Japan, Takeda, Sato Hospitals, Horii clinic
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	京都大学大学院医学研究科　腎臓内科

Other administrative information
Date of disclosure of the study information	2012 Year 03 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 13 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date	2017 Year 04 Month 04 Day
Date of closure to data entry	2017 Year 09 Month 24 Day
Date trial data considered complete	2017 Year 09 Month 24 Day
Date analysis concluded	2017 Year 09 Month 24 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 03 Month 13 Day
Last modified on	2018 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008840