UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011237 |
|---|---|
| Receipt number | R000013138 |
| Scientific Title | The Relationship between the dose of Epoetin Beta Pegol for treatment of renal anemia and renal prognosis in CKD Patients |
| Date of disclosure of the study information | 2013/07/20 |
| Last modified on | 2020/03/31 20:07:12 |
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Basic information
Public title
The Relationship between the dose of Epoetin Beta Pegol for treatment of renal anemia and renal prognosis in CKD Patients
Acronym
The Relationship between the dose of Epoetin Beta Pegol and renal prognosis in CKD Patients
Scientific Title
The Relationship between the dose of Epoetin Beta Pegol for treatment of renal anemia and renal prognosis in CKD Patients
Scientific Title:Acronym
The Relationship between the dose of Epoetin Beta Pegol and renal prognosis in CKD Patients
Region
| Japan |
Condition
Condition
renal anemia in CKD patients not on hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the renal prognosis by doses of epoetin beta pegol to maintenance the target hemoglobin level of renal anemia in CKD patients not on hemodialysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Renal prognosis
1) time to doubling of serum creatinine level
2) time to entry in a hemodialysis
3) time to decreace in eGFR to less than 6.0 mL/min/1.73 m2
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)CKD patients not on dialysis with the hemoglobin level less than 11g/dL
(2)Patients with no prior treatment with ESA agents
Key exclusion criteria
(1) Anemia for other reasons than the renal anemia:
1) Iron deficiency (Serum ferritin <100 ng/mL and transferrin saturation <20%)
2) Vitamin B12 deficiency
3) Folic acid deficiency
4) Apparent hemorrhagic lesion
5) hematologic disease (e.g. leukemia, malignant lymphoma, myelodysplastic syndrome, aplastic anemia)
6) Disease associated with chronic inflammation (e.g. rheumatoid arthritis, inflammatory bowel disease)
7) Under myelosuppressive therapy (immunosuppressive therapy, chemotherapy or radiotherapy)
(2) Under treatment for malignansy and severe infection
(3) Post renal transplant patient
(4) Hypersensitivity to epoetin beta pegol
(5) Pregnancy or lactating
(6) eGFR <6.0 mL/min/1.73 m2
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | JUN |
| Middle name | |
| Last name | Jun |
Organization
Toda Central General Hospital
Division name
Department of Nephrology
Zip code
335-0023
Address
1-19-3 Hon-chyou Toda city, Saitama
TEL
048-442-1111
pikkun46@umin.or.jp
Public contact
Name of contact person
| 1st name | JUN |
| Middle name | |
| Last name | Jun |
Organization
Toda Central General Hospital
Division name
Department of Nephrology
Zip code
335-0023
Address
1-19-3 Hon-chyou Toda city, Saitama
TEL
048-442-1111
Homepage URL
pikkun46@umin.or.jp
Sponsor or person
Institute
Toda Central General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of Toda Central General Hospital
Address
1-19-3 Hon-cho, Toda city, Saitama, 335-0023, Japan
Tel
048-442-1111
iryouhisho@chuobyoin.or.jp
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 | 07 | Month | 20 | 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
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective study to evaluate that the effect of epoetin beta pegol to accomplish the target Hb level and the relationship between doses of tha agent and renal prognosis for two-year observation. Moreover we will analyze which urine and serum markers would influence the renal prognosis.
Management information
Registered date
| 2013 | Year | 07 | Month | 20 | Day |
Last modified on
| 2020 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013138
