UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009472 |
|---|---|
| Receipt number | R000011078 |
| Scientific Title | Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease |
| Date of disclosure of the study information | 2012/12/04 |
| Last modified on | 2017/12/07 11:12:02 |
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Basic information
Public title
Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease
Acronym
Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease
Scientific Title
Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease
Scientific Title:Acronym
Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease
Region
| Japan |
Condition
Condition
Renal anemia in chronic kidney disease
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the response to rHuEPO or epoetin beta pegol for the treatment of renal anemia in patients with chronic kidney disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1)Comparison of changes in hepcidin concentrations between patients treated with rHuEPO or those treated with epoetin beta pegol
(2)Identification of factors affecting the treatment response to rHuEPO or epoetin beta pegol
Key secondary outcomes
(1)Effects of rHuEPO and epoetin beta pegol on iron metabolism
(2)Changes in dosage of epoetin beta pegol and Hb level
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CERA Group:
Epoetin beta pegol is subcutaneously administered once every two weeks.
Interventions/Control_2
rHuEPO Group:
rHuEPO is subcutaneously administered once every two weeks.
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 no prior treatment with ESA
(2)Patients 20 years old or older at time of study initiation
(3)Patients with a hemoglobin (Hb) level of >= 8 g/dL and < 11 g/dL
(4)Patients with eGFR of < 60 mL/min/1.73m2
(5)Patients who give written informed consent
Key exclusion criteria
(1)Patients on hemodialysis or peritoneal dialysis
(2)Patients who underwent renal transplant
(3)Patients with malignancy or hematological diseases (such as MDS)
(4)Patients with severe complications, such as severe infections
(5)Patients who take iron therapy
(6)Patients who are judged to be ineligible by an attending doctor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Mitsuiki |
Organization
Fukuoka Red Cross Hospital
Division name
Division of Nephrology
Zip code
Address
3-1-1 Ohgusu, Minami-ku, Fukuoka
TEL
092-551-1211
koji@fukuoka-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Mitsuiki |
Organization
Fukuoka Red Cross Hospital
Division name
Division of Nephrology
Zip code
Address
3-1-1 Ohgusu, Minami-ku, Fukuoka
TEL
092-551-1211
Homepage URL
koji@fukuoka-med.jrc.or.jp
Sponsor or person
Institute
Fukuoka Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Red Cross Hospital, Kyushu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
福岡赤十字病院（福岡県）,九州大学（福岡県）,宗像医師会病院（福岡県）,九州医療センター（福岡県）,原三信病院（福岡県）,福岡東医療センター（福岡県）,浜の町病院（福岡県）,白十字病院（福岡県）,小倉記念病院（福岡県）,飯塚病院（福岡県）,掖済会門司病院（福岡県）,製鉄記念八幡病院（福岡県）,聖マリア病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 03 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 03 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 03 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 03 | Day |
Last modified on
| 2017 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011078
