UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007494 |
|---|---|
| Receipt number | 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 23:10:14 |
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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
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
yokoih@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008840
