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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001285
Receipt No. 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

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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
Email

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/
Email m-koremoto@umin.ac.jp

Sponsor
Institute The Society of Vitamembrane
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001567

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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