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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010357
Receipt No. R000010574
Scientific Title Effect of the use of dialyzer having excellent performance for removal of cytokines on clinical observation in maintenance HD patients
Date of disclosure of the study information 2013/04/01
Last modified on 2014/11/07

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Basic information
Public title Effect of the use of dialyzer having excellent performance for removal of cytokines on clinical observation in maintenance HD patients
Acronym Tokai Cytokine Removal Study
Scientific Title Effect of the use of dialyzer having excellent performance for removal of cytokines on clinical observation in maintenance HD patients
Scientific Title:Acronym Tokai Cytokine Removal Study
Region
Japan

Condition
Condition Hypercytokinemia in maintenance hemodialysis patients
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective is to determine whether the use of the dialyzer having excellent performance for removal of cytokines can reduce blood cytokine (IL-6) levels and improve clinical observation in maintenance hemodialysis patients with a high inflammatory status.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Removal performance of pro-inflammatory cytokine (IL-6). (Clearance is measured at 1 and 4 hr after the beginning of session. Removal rate is measured at 4 hr after the beginning of session.)
2) Blood concentration of inflammatory cytokine (IL-6) is measured every four months for one year. Sample is collected before each session.
3) Clinical observation (MIS evaluation) are recorded every four months for one year.
Key secondary outcomes 1) Dialysis dose: BUN(KT/V), B2-MG
2) Physique, electrolyte: BMI, Na, K, Cl, chest x-ray (CTR)
3) Mineral metabolism: P, Ca, int-PTH
4) Anemia: Hb, ESA dose, serum TIBC
5) Nutritional status: Alb
6) Inflammatory status: high sensitive CRP
7) Hemodynamics: blood pressure at 0, 30, 60, 120, 180, and 240 minutes after the beginning of session.
8) Clinical observation: Clinical observations are described in the following 3 items.
(1) Atherosclerosis (cold feeling in lower leg, paralysis).
(2) Eating disorder and nutritional status.
(3) Inflammatory status.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The use of dialyzer having excellent performance for removal of cytokines.
Interventions/Control_2 The use of conventional dialyzers.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Stable hemodialysis patients who are receiving hemodialysis more than 7 years.
2) Patients who are using polysulfone dialyzers (PS, PES, PEPA) other than NV series.
Key exclusion criteria 1) Patients who are receiving renal replacement therapies other than hemodialysis, continuous ambulatory peritoneal dialysis and hemodiafiltration, excluding hemodialysis.
2) Patients who are enrolled to other clinical study.
3) Cancer bearing patients or a patient who received radical surgery for cancer in less than 3 years.
4) Patients who have a history of cardiovascular diseases (myocardial infarction, stroke) in less than 6 months.
5) Patients who have peripheral arterial disease classified in more than Fontaine classification class II.
6) Patients who have uncontrolled diabetes despite standard treatments.
7) Patients who are considered to have acute inflammation with CRP of higher than 2 mg/dL.
8) Patients with uncontrolled anemia (Hb <8.5 g/dL) despite ESA treatment.
9) Patients who are pregnant or intends to become pregnant within one year.
10) Patients who are judged as the inadequate subject of this study by the doctor.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takatoshi Kakuta
Organization Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code
Address 143 Shimo-Kasuya, Isehara, Japan
TEL 0463-93-1121
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takatoshi Kakuta
Organization Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code
Address 143 Shimo-Kasuya, Isehara, Japan
TEL 0463-93-1121
Homepage URL
Email kakuta@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai Cytokine Removal Study Group
Institute
Department

Funding Source
Organization Toray Medical Co.
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
2013 Year 04 Month 01 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
2012 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 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
2013 Year 03 Month 29 Day
Last modified on
2014 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010574

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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