UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008531 |
|---|---|
| Receipt number | R000010032 |
| Scientific Title | Comparative study of the sustained erythropoiesis-stimulating agents in patients with chronic kidney disease at predialysis stage |
| Date of disclosure of the study information | 2013/12/31 |
| Last modified on | 2016/03/04 16:17:43 |
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Basic information
Public title
Comparative study of the sustained erythropoiesis-stimulating agents in patients with chronic kidney disease at predialysis stage
Acronym
Comparative study of the sustained ESA in patients with CKD at prdialysis stage
Scientific Title
Comparative study of the sustained erythropoiesis-stimulating agents in patients with chronic kidney disease at predialysis stage
Scientific Title:Acronym
Comparative study of the sustained ESA in patients with CKD at prdialysis stage
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the clinical efficacy and safety of darbepoetin and CERA in CKD patient with anemia treatment at predialysis stage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maintenance rate of traget Hb at weeks 24 and 48
Change rate of eGFR at weeks 24 and 48
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
darbepoetin
Interventions/Control_2
CERA
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
The patients who receive subcutaneous administration of darbepoetin once in four weeks more than 24 weeks
The patients whom Hb level of most recent 12 weeks is maintained over 9.5 g/dL
The patients whom darbepoetin dosage of most recent 12 weeks is stable
The patients whom ferritin level at study initiation is over 80 ng/mL
Key exclusion criteria
The patients who received transfusion within the past 24 weeks
The patients who refused subcutaneous injection
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Okada |
Organization
Itabashi Hospital, Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension and Endocrinology
Zip code
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Clinical Research Institutional Review Board
Division name
Clinical Research Center
Zip code
Address
TEL
Homepage URL
hirukawa.yasuko@nihon-u.ac.jp
Sponsor or person
Institute
Division of Nephrology, Hypertension and Endocrinology, Itabashi Hospital, Nihon University School of Medicn
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Hypertension and Endocrinology, Itabashi Hospital, Nihon University School of Medicn
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 31 | 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 | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 25 | Day |
Last modified on
| 2016 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010032
