UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006963 |
|---|---|
| Receipt number | R000008220 |
| Scientific Title | The effect of intervention with darbepoetin alfa on progression of renal decline[chronic renal failure?] in renal anaemia patients with chronic kidney disease not on dialysis. |
| Date of disclosure of the study information | 2011/12/27 |
| Last modified on | 2014/06/27 15:55:31 |
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Basic information
Public title
The effect of intervention with darbepoetin alfa on progression of renal decline[chronic renal failure?] in renal anaemia patients with chronic kidney disease not on dialysis.
Acronym
Renal function is sustained by renal anemia inprovement using Nesp.- Juntendo
(REFRAIN -J study)
Scientific Title
The effect of intervention with darbepoetin alfa on progression of renal decline[chronic renal failure?] in renal anaemia patients with chronic kidney disease not on dialysis.
Scientific Title:Acronym
Renal function is sustained by renal anemia inprovement using Nesp.- Juntendo
(REFRAIN -J study)
Region
| Japan |
Condition
Condition
renal anaemia patients with chronic kidney disease not on dialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object is to investigate the impact on progression of renal decline for darbepoetin alfa,when maintaining it to Hb 11g/dL or more in renal anaemia patients with chronic kidney disease not on dialysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in kidney function after two years
(The changes in renal function after darbepoetin alfa treatment)
Key secondary outcomes
1.Changes of biochemical makers in sera
2.Stratification comparison by inspection items (level of Hb and eGFR)
**Stratified analyses using baseline Hb level and doses of darbepoetin alfa
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Darbepoetin alfa is administered to renal anaemia patients with chronic kidney disease not on dialysis and it maintains it to Hb value 11g/dL or more.
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
*Patients with chronic kidney disease not on dialysis.[Non-dialysis CKD patients]
*Patients with renal anemia, their levels of Hb are less than 11g/dL
*20 years of age and older
Key exclusion criteria
*Patient without renal anemia
*Patient having hypersensitivity to rHuEPO.
*Level of Hb is more than 13g/dL
*Patients with anemia caused by conditions other than renal anemia such as GI bleeding and blood desease
*Patients with serious allergies or serious drug sensitivities
*Patients with severe complications
*Pregnant or possibly pregnant and lactaing women
*Ineligible patients according to the investigator's judgment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Tomino |
Organization
Department of Internal Medicine,juntendo University Faculty of Medicine
Division name
Division of Nephrology
Zip code
Address
2-1-1 Hongo,Bunkyo ward,Tokyo,Japan
TEL
03-5802-1065
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chieko Hamada |
Organization
Department of Internal Medicine,juntendo University Faculty of Medicine
Division name
Division of Nephrology
Zip code
Address
2-1-1 Hongo,Bunkyo ward,Tokyo,Japan
TEL
03-5802-1065
Homepage URL
chieko@juntendo.ac.jp
Sponsor or person
Institute
Division of Nephrology,Department of Internal Medicine,Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo Clinical Research Center, Juntendo University Faculty of Medicine
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
順天堂大学医学部附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 27 | 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
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 27 | Day |
Last modified on
| 2014 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008220
