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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017326
Receipt No. 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

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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
Email 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
Email kuwaharam@shuuwa-gh.or.jp

Sponsor
Institute Shuuwa General Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020100

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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