UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021774
Receipt No. R000025106
Scientific Title Renal anemia treatment in chronic kidney disease patients
Date of disclosure of the study information 2016/04/04
Last modified on 2017/11/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Renal anemia treatment in chronic kidney disease patients
Acronym Renal anemia treatment in chronic kidney disease patients
Scientific Title Renal anemia treatment in chronic kidney disease patients
Scientific Title:Acronym Renal anemia treatment in chronic kidney disease patients
Region
Japan

Condition
Condition Renal anemia in chronic kidney disease patients
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Te determine the effect of anemia treated by erythropoiesis-stimulating agents (ESAs) on the onset of cardiovascular events and the survival rate
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the incidence of CVEs and the survival rate during ESAs administration in three kinds of ESAs [epoetin(EPO), darbepoetin alpha(DPO), and epoetin beta pegol(EPObp)]
Key secondary outcomes To compare the frequency of adverse events and degree of increase in hemoglobin (Hb) in three kinds of ESAs (EPO, DPO, and EPObp)

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 that are 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 300

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

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 04 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
This research was formulated and promoted by Mr. Michio Kuwabara (M.K.), the research director. However, M.K. moved from Shuuwa General Hospital to another hospital from April 1, 2017 because of personnel change. M.K. asked seven colleagues in Shuuwa General Hospital about intention to continue this research, but no one had the intention for various reasons. Therefore, M.K. had to cancel this research.
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 Terminated
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
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a prospective observational study. Among the patients that visited the Department of Nephrology of Shuuwa General Hospital after April 4, 2005, all patients that fulfilled the inclusion criteria were enrolled in this study.

Management information
Registered date
2016 Year 04 Month 04 Day
Last modified on
2017 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025106

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.