UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009882
Receipt number R000011561
Scientific Title The investigation of the clinical factor against renal detorioration in our predialytic patients with chronic kidney disease
Date of disclosure of the study information 2013/01/28
Last modified on 2013/01/28 14:08:21

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Basic information

Public title

The investigation of the clinical factor against renal detorioration in our predialytic patients with chronic kidney disease

Acronym

The supression factor against CRF in predialytic patients with CKD

Scientific Title

The investigation of the clinical factor against renal detorioration in our predialytic patients with chronic kidney disease

Scientific Title:Acronym

The supression factor against CRF in predialytic patients with CKD

Region

Japan


Condition

Condition

our predialytic patients with CKD treated by our predialytic treatment protocol in Aso-Iizuka Hospital (ex:antihypertensive therapy, low protein diet, sodium restriction)

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

understanding of real our predialytic treatment in our hospital, the prognosis of our patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

the induction of dialysis, death, CVD onset,

Key secondary outcomes

the duration and frequency of admission, ADL, renal dysfunction rate, the differenses between DM and non-DM, life survival, the frequency of infection


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Food Device,equipment

Interventions/Control_1

nutrition control

Interventions/Control_2

control of BP

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

performed or not, predialytic protocal treatment in Aso-Iizuka Hospital

Key exclusion criteria

non-compliance or drop-out cases

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhito Takeda

Organization

Aso-Iizuka Hospital

Division name

Department of Nephrology

Zip code


Address

3-83 Yoshio-Cho, Iizuka City

TEL

0948-22-3800

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazuhito Takeda

Organization

Aso-Iizuka Hospital

Division name

Department of Nephrology

Zip code


Address


TEL

0948-22-3800

Homepage URL


Email



Sponsor or person

Institute

Aso-Iizuka Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

2013 Year 01 Month 28 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

Open public recruiting

Date of protocol fixation

2001 Year 04 Month 10 Day

Date of IRB


Anticipated trial start date

2001 Year 04 Month 10 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 01 Month 28 Day

Last modified on

2013 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011561


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name