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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021659
Receipt No. R000024977
Scientific Title Long-acting CERA significantly increases circulating CD34-positive cells compared with short-acting epoetin-beta in patients undergoing hemodialysis
Date of disclosure of the study information 2016/03/29
Last modified on 2016/03/29

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Basic information
Public title Long-acting CERA significantly increases circulating CD34-positive cells compared with short-acting epoetin-beta in patients undergoing hemodialysis
Acronym Effects of CERA on circulating EPC levels
Scientific Title Long-acting CERA significantly increases circulating CD34-positive cells compared with short-acting epoetin-beta in patients undergoing hemodialysis
Scientific Title:Acronym Effects of CERA on circulating EPC levels
Region
Japan

Condition
Condition patients with chronic renal failure undergoing hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated the effect of two different types of ESAs, long-acting continuous erythropoietin receptor activator (CERA) and short-acting epoetin-beta (Epo), on the number of circulating EPCs.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effects of CERA and epoetin-beta on numbers of circulating endothelial progenitor cells
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients were randomly assigned to CERA treatment for 6 months.
Interventions/Control_2 Patients were randomly assigned to Epoetin-beta treatment for 6 months.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients whose hemoglobin concentration are within 11+/- 1.0 g/dl during the last 3 months.
Key exclusion criteria Exclusion criteria were concomitant chronic inflammatory diseases or clinically manifest acute infections, malignant diseases, manifest or occult bleeding conditions, and recent cardiovascular events (at least 6 months).
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sumi Hidaka
Organization Shonan Kamakura General Hospital
Division name Kidney Disease and Transplant Center
Zip code
Address Okamoto 1370-1, Kamakura, Japan
TEL +81-467-46-1717
Email s_hidaka@shonankamakura.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sumi Hidaka
Organization Shonan Kamakura General Hospital
Division name Kidney Disease and Transplant Center
Zip code
Address Okamoto 1370-1, Kamakura, Japan
TEL +81-467-46-1717
Homepage URL
Email s_hidaka@shonankamakura.or.jp

Sponsor
Institute Shonan Kamakura General Hospital
Institute
Department

Funding Source
Organization This work was kindly supported by grant for pathophysiological research conference in chronic kidney disease from The Kidney Foundation, Japan (JKFB13-16)
Organization
Division
Category of Funding Organization Non profit foundation
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 03 Month 29 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 05 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 29 Day
Last modified on
2016 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024977

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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