UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006439
Receipt number R000007642
Scientific Title Study of Adaptable Patients with type V dialyzer by the Nutrition index.
Date of disclosure of the study information 2011/09/29
Last modified on 2017/04/03 17:21:34

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Basic information

Public title

Study of Adaptable Patients with type V dialyzer by the Nutrition index.

Acronym

Study of Adaptable Patients with type V dialyzer by the Nutrition index.(APEAN-STUDY)

Scientific Title

Study of Adaptable Patients with type V dialyzer by the Nutrition index.

Scientific Title:Acronym

Study of Adaptable Patients with type V dialyzer by the Nutrition index.(APEAN-STUDY)

Region

Japan


Condition

Condition

End stage renal disease

Classification by specialty

Medicine in general Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of dialyzer flux on patients' nutrition

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Serum albumin (pre-dialysis)

Key secondary outcomes

Secondary endpoint-1:for all patients
Serum creatinine, blood test, body weight, UN, BMI, serum iron, serum CRP, dialysate's name, dialsate's endtoxin, ESA's dosage, ultrafiltration volume
Secondary endpoint-2:for parts of patients
Serum transferrin, TIBC, serum ferritin, iron dosage, anti-hypertension agents' dosage, bacteria, beta2-microgroburin, alpha1-microgroburin


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Hemodialysis using APS-EA

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

All content are requested in the following.
1.Hemodialysis vintage more than one year
2.serum creatinine's value more than 6.0 mg/mL
3.serum albumin's value more than 3.0 g/dL
4.BMI more than 18
5.nothing more than NYHA 3 degree as clinical judge
6.without dementia
7.received informed consent and signed agreement sheet before study

Key exclusion criteria

Either content is full in the following
1.in treating with adsorption column for beta2-microglobrin
2.medical doctor assigned to be ineligible

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaki Nagasawa

Organization

Shinonoi General Hospital

Division name

Nephrology

Zip code


Address

666-1, Shinonoikai, Nagano-shi, Nagano

TEL

026-292-2261

Email

sgh_cle@grn.janis.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masaki Nagasawa

Organization

APEAN-STUDY Group

Division name

Japan Culture and Welfare Federation of Agricultural Cooperatives APEAN STUDY Group

Zip code


Address

Yoyogi 2-5-5, Shibuya, Tokyo

TEL

03-3370-2597

Homepage URL


Email

sgh_cle@grn.janis.or.jp


Sponsor or person

Institute

APEAN-STUDY Group

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

白河厚生総合病院、塙厚生病院、篠ノ井総合病院、下伊那厚生病院、茨城西南医療センター病院、仙北組合総合病院、平鹿総合病院、廣島総合病院、久喜総合病院、吉田総合病院、鈴鹿中央総合病院、土浦協同病院、小諸厚生総合病院、坂下厚生総合病院、水戸協同病院、北信総合病院、菰野厚生病院、周東総合病院、長門総合病院、小郡第一総合病院


Other administrative information

Date of disclosure of the study information

2011 Year 09 Month 29 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

2011 Year 09 Month 07 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 07 Day

Last follow-up date

2012 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 09 Month 29 Day

Last modified on

2017 Year 04 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007642


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name