UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001285 |
|---|---|
| Receipt number | R000001567 |
| Scientific Title | A prospective multicenter study of Vitamin E bonded polysulfone membrane for Erythropoiesis Stimulation Agents in Hemodialysis Patients |
| Date of disclosure of the study information | 2008/08/07 |
| Last modified on | 2013/08/02 15:04:39 |
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Basic information
Public title
A prospective multicenter study of Vitamin E bonded polysulfone membrane for Erythropoiesis Stimulation Agents in Hemodialysis Patients
Acronym
VEESA-study
Scientific Title
A prospective multicenter study of Vitamin E bonded polysulfone membrane for Erythropoiesis Stimulation Agents in Hemodialysis Patients
Scientific Title:Acronym
VEESA-study
Region
| Japan |
Condition
Condition
end-stage renal disease hemodialysis patients with renal anemia
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To inspect whether vitamin E bonded dialyzer is able to improve for anemia of hemodialysis patient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To observasion of dosage for erythropoiesis stimulation agents which is need to maintain Hb at the initial point with vitamin E bonded dialyzer:VPS-HA.
Key secondary outcomes
peripheral blood general tests (hemoglobin, hematocrit, red blood cell counts, white blood cell counts, platelets counts), reticulocyte counts, serum iron, serum ferritin, serum transferrin, serum total iron binding capacity (TIBC), indirect bilirubin, serum high sensitive CRP, red blood cell distribution width, the dosage of iron medicine, a species / dosage of the antihypertensive agent, the dialysate endotoxin value. In addition, the event of the cardiovascular diseases by accumulation in two years.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Object group : with vitamin E bonded polysulfone membrane dialyzer (VPS-HA), Hb range is matched 10 to 11 g/dL as Hb at the initial point.
Interventions/Control_2
Control group : with type 4 polysulfone membrane dialyzer, Hb range is matched 10 to 11 g/dL as Hb at the initial point.
Interventions/Control_3
Object group : with vitamin E bonded polysulfone membrane dialyzer (VPS-HA), Hb range is matched 11 to 12 g/dL as Hb at the initial point.
Interventions/Control_4
Control group : with type 4 polysulfone membrane dialyzer, Hb range is matched 11 to 12 g/dL as Hb at the initial point.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who is dialyzed by the same type 4 polysulfone dialyzer (except for the change of membrane size ) for more than three months. The patient whose TSAT is more than 20% as average of three months, and who is addiministrated with same ESA in the past three months, and whose Hb range in 10 to 12 g/dL as average of three months. In addition, after informed with an explanation document attached an agreement sheet separately, a patient whose consent was obtained.
Key exclusion criteria
The hemodialysis patient with normal polycystic kidney disease. In addition, the incompetent patient who was rejected by a doctor.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAKAHIRO MOCHIZUKI |
Organization
Kameda Medical Center
Division name
Nephrology
Zip code
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, 296-8602, Japan
TEL
04-7092-2211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MASAHIDE KOREMOTO |
Organization
The Society of Vitamembrane Secretariat
Division name
Scientific and Technical Affairs Department, Dialysis Products Division, Asahikasei Kuraray Medical
Zip code
Address
1-105 Kanda Jinbocho, Chiyoda-ku, Tokyo 101-8101, Japan
TEL
03-3296-3723
Homepage URL
https://center.umin.ac.jp/islet/veesa/
m-koremoto@umin.ac.jp
Sponsor or person
Institute
The Society of Vitamembrane
Institute
Department
Personal name
Funding Source
Organization
Asahikasei Kuraray Medical Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2008 | Year | 08 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://cjasn.asnjournals.org/content/8/6/969.long
Number of participants that the trial has enrolled
Results
Sanaka T, Mochizuki T, Kinugasa E, Kusano E, Ohwada S, Kuno T, Kojima K, Kobayashi S, Satoh M, Shimada N, Nakao K, Nakazawa R, Nishimura H, Noiri E, Shigematsu T, Tomo T, Maeda T; VEESA Study Group.
Randomized controlled open-label trial of vitamin E-bonded polysulfone dialyzer and erythropoiesis-stimulating agent response.
Clin J Am Soc Nephrol. 2013 Jun;8(6):969-78
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
| 2008 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 02 | Day |
Last modified on
| 2013 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001567
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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