UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027562
Receipt number R000031597
Scientific Title The evaluation of Plasma Cyclops with blood specimens from hemodialysis patients
Date of disclosure of the study information 2017/06/01
Last modified on 2017/05/31 10:33:57

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Basic information

Public title

The evaluation of Plasma Cyclops with blood specimens from hemodialysis patients

Acronym

The evaluation of Plasma Cyclops

Scientific Title

The evaluation of Plasma Cyclops with blood specimens from hemodialysis patients

Scientific Title:Acronym

The evaluation of Plasma Cyclops

Region

Japan


Condition

Condition

Kidney disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clinical utility of the new blood collection tube (Plasma Cyclops) for hemodialysis patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation with existing serum tubes for general chemical analytes.

Key secondary outcomes

Improvement of the specimens quality, such as fibrin deposition.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

-Patients receiving heparin as anticoagulant therapy
-Hemoglobin (Hb) level of 9.0 g/dL or higher before dialysis sessions (including patients treated with ESA [erythropoiesis-stimulating agent])
-Patients undergoing dialysis for more than 1 month after initiation of dialysis
-Patients who do not simultaneously receive treatment for acute illness
-Patients without blood diseases or abnormal coagulation system

Key exclusion criteria

-Pregnant women
-Patients with a large change in blood pressure during dialysis
-Patients who are considered inappropriate as a subject by the attending physician
-Patients who have participated in this study
-Patients incapable of making a decision regarding participation in this study

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazumasa Usami

Organization

Taigenkai Hospital

Division name

Internal Medicine

Zip code


Address

Higashi-Itsushiro1-1, Ichinomiya City, Aichi Prefecture, Japan

TEL

0586-61-2121

Email

taigenkai@qclinx.net


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Tomaru

Organization

Nippon Becton Dickinson Company, Ltd.

Division name

Medical Affairs

Zip code


Address

Akasaka4-15-1, Minato-ku, Tokyo, Japan

TEL

03-6234-5490

Homepage URL


Email

takeshi.tomaru@bd.com


Sponsor or person

Institute

Nippon Becton Dickinson Company, Ltd
Medical Affairs

Institute

Department

Personal name



Funding Source

Organization

Nippon Becton Dickinson Company, Ltd
Medical Affairs

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



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

2017 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

2014 Year 12 Month 29 Day

Date of IRB


Anticipated trial start date

2015 Year 03 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None.


Management information

Registered date

2017 Year 05 Month 31 Day

Last modified on

2017 Year 05 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031597


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name