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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007494
Receipt No. R000008840
Scientific Title Efficacy of erythropoietin beta pegol assessment study with kidney diseases.
Date of disclosure of the study information 2012/03/13
Last modified on 2018/04/17

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Basic information
Public title Efficacy of erythropoietin beta pegol assessment study with kidney diseases.
Acronym EPACME Study (ErythroPoietin Assessment in CKD patients by Metabolic and Endocrinological factors)
Scientific Title Efficacy of erythropoietin beta pegol assessment study with kidney diseases.
Scientific Title:Acronym 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
1st name
Middle name
Last name Hideki Yokoi
Organization Kyoto University Graduate School of Medicine
Division name Department of Nephrology
Zip code
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
1st name
Middle name
Last name Hideki Yokoi
Organization Kyoto Univesity Graduate School of Medicne
Division name Department of Nephrology
Zip code
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)

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 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

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
2012 Year 03 Month 13 Day
Date of IRB
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

Other
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

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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