UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017326 |
|---|---|
| Receipt number | R000020100 |
| Scientific Title | Difference of early response to renal anemia in erythropoiesis-stimulating agents. |
| Date of disclosure of the study information | 2015/04/29 |
| Last modified on | 2016/11/02 08:20:04 |
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Basic information
Public title
Difference of early response to renal anemia in erythropoiesis-stimulating agents.
Acronym
Difference of early response to renal anemia in erythropoiesis-stimulating agents
Scientific Title
Difference of early response to renal anemia in erythropoiesis-stimulating agents.
Scientific Title:Acronym
Difference of early response to renal anemia in erythropoiesis-stimulating agents
Region
| Japan |
Condition
Condition
Chronic kidney disease with renal anemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate difference of early response to renal anemia in three different erythropoiesis-stimulating agents [epoetin(EPO), darbepoetin alpha(DPO), and epoetin beta pegol(EPObp)] and to determine factors which affected the responsiveness to renal anemia in each erythropoiesis-stimulating agent.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
After 12 wk administration of erythropoiesis-stimulating agent (ESA), the degree of increase in hemoglobin adjusted by body weight and amount of ESA was compared in three kinds of ESAs.
Key secondary outcomes
After 12 wk administration of erythropoiesis-stimulating agent (ESA), factors which affected the responsiveness to renal anemia was determined in each ESA.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Chronic kidney disease patients with renal anemia who were required to treat by erythropoiesis-stimulating agents.
Key exclusion criteria
Patients complicated with potential diseases causing anemia such as hemorrhagic disease, hematological disease, or carcinoma.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Kuwahara |
Organization
Shuuwa General Hospital
Division name
Department of Nephrology
Zip code
Address
1200 Yahara-Shinden, Kasukabe, Saitama 344-0035, Japan
TEL
048-737-2121
kuwaharam@shuuwa-gh.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Kuwahara |
Organization
Shuuwa General Hospital
Division name
Department of Nephrology
Zip code
Address
1200 Yahara-Shinden, Kasukabe, Saitama 344-0035, Japan
TEL
048-737-2121
Homepage URL
kuwaharam@shuuwa-gh.or.jp
Sponsor or person
Institute
Shuuwa General Hospital
Institute
Department
Personal name
Funding Source
Organization
None.
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
秀和総合病院(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The efficacy of DPO and EPObp were similar and significantly higher than EPO. transferrin saturation (TSAT) was most strongly correlated with delta Hb/EPO dose/kg in all three types of ESAs. Other significant independent factors were Hb, albumin, P, iPTH, and diabetic nephropathy in the EPO group, eGFR in the DPO group, and Fe in the EPObp group. The adjusted coefficient of determination (R2) ranged from 0.415-0.520 in the three ESA groups.
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
| 2005 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 20 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 20 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 15 | Day |
Other
Other related information
prospective observational study
Management information
Registered date
| 2015 | Year | 04 | Month | 29 | Day |
Last modified on
| 2016 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020100
