UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039224
Receipt number R000044716
Scientific Title Prospective Observational Study for the Optimal Initiation of Dialysis treatment
Date of disclosure of the study information 2020/02/01
Last modified on 2023/07/26 09:49:42

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Basic information

Public title

Prospective Observational Study for the Optimal Initiation of Dialysis treatment

Acronym

Prospective Observational Study for the Optimal Initiation of Dialysis treatment

Scientific Title

Prospective Observational Study for the Optimal Initiation of Dialysis treatment

Scientific Title:Acronym

Prospective Observational Study for the Optimal Initiation of Dialysis treatment

Region

Japan


Condition

Condition

End-stage renal disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study will reveal the relationship between the medical conditions at the first visit to nephrologists, or at the beginning of dialysis treatment, or the cost for initiation of dialysis and the patient's prognosis. The purpose of this study is to establish the optimal approach for initiation of dialysis treatment.

Basic objectives2

Others

Basic objectives -Others

Prospective Observational Study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Alive or death three years after the initiation of dialysis

Key secondary outcomes

1) Basic information; Age, Sex, Original disease, Medical history, Internal medicines
2) About the first visit; Date, What hospital or clinic did the patient visit before the first visit, CKD stage
3) About initiation of dialysis treatment; Date, Age, Hight, Body weight, Blood pressure, Blood test (BUN, Cre, eGFR, Hb, TSAT, ALB, Na, K, Ca, P, iPTH, HbA1c, Gly-A, TG, LDL-chol, HDL-chol, and CRP), Planned or emergency start of dialysis treatment, Chest X-ray findings, Ultrasonic cardiography findings
4) About the vascular access; Type, Date of operation, When the access had been used first, Vascular ultrasound findings before and after one week the operation
5) Medical fees when the patient hospitalized for initiation of dialysis treatment
6) Until 3 years after initiation of dialysis; History of hospitalization, vascular access troubles, disdialysis syndrome, Urine volume, EQ-5D score


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

130 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who had been started dialysis treatment from January 2018 to December 2020 in Juntendo University Hospital

Key exclusion criteria

The patients who had received a kidney transplant within 2 years after the initiation of dialysis treatment

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Junichiro
Middle name
Last name Nakata

Organization

Juntendo University Faculity of Medicine

Division name

Department of Nephrology

Zip code

113-8431

Address

3-1-3, Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

jnakata@juntendo.ac.jp


Public contact

Name of contact person

1st name Junichiro
Middle name
Last name Nakata

Organization

Juntendo University Faculity of Medicine

Division name

Department of Nephrology

Zip code

113-8431

Address

3-1-3, Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL


Email

jnakata@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University Faculity of Medicine

Institute

Department

Personal name



Funding Source

Organization

self funding

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

the Ethics Committee of Juntendo University Hospital

Address

3-1-3, Hongo, Bunkyo-ku, Tokyo

Tel

0338133111

Email

kenkyu5858@juntendo.ac.jp


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

順天堂大学医学部附属順天堂医院 腎・高血圧内科 (東京都)
順天堂大学医学部附属練馬病院 腎・高血圧内科 (東京都)
江東病院 腎臓内科 (東京都)
順天堂大学医学部附属順天堂東京江東高齢者医療センター 腎・高血圧内科 (東京都)
順天堂大学医学部附属静岡病院 腎・高血圧内科 (静岡県)
順天堂大学医学部附属浦安病院 腎・高血圧内科 (千葉県)


Other administrative information

Date of disclosure of the study information

2020 Year 02 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

400

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

No longer recruiting

Date of protocol fixation

2017 Year 11 Month 24 Day

Date of IRB

2017 Year 11 Month 24 Day

Anticipated trial start date

2018 Year 01 Month 01 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

analysis in progress


Management information

Registered date

2020 Year 01 Month 22 Day

Last modified on

2023 Year 07 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044716


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name