UMIN-CTR Clinical Trial

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

Hypercytokinemia in maintenance hemodialysis patients

Classification by specialty

Medicine in general	Endocrinology and Metabolism	Nephrology
Urology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokai Cytokine Removal Study Group

Institute

Department

Personal name

Organization

Toray Medical Co.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

03

Month

29

Day

Last modified on

2014

Year

11

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010574