UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021659 |
|---|---|
| Receipt number | 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 00:31:41 |
* 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
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
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
s_hidaka@shonankamakura.or.jp
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
