UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037871 |
|---|---|
| Receipt number | R000043122 |
| Scientific Title | Observational Study for the Optimal Initiation of Dialysis treatment |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2021/01/12 15:14:20 |
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Basic information
Public title
Observational Study for the Optimal Initiation of Dialysis treatment
Acronym
Observational Study for the Optimal Initiation of Dialysis treatment
Scientific Title
Observational Study for the Optimal Initiation of Dialysis treatment
Scientific Title:Acronym
Observational Study for the Optimal Initiation of Dialysis treatment
Region
| Japan |
Condition
Condition
end stage kidney 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 nephrologist, or at the beginning of dialysis treatment, or the cost for initiation of dialysis treatment 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
retrospective observational study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Alive or death two 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 4 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 September 2013 to August 2015 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
450
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
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
jnakata@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
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
03-3813-3111
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)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | 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
151
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
| 2017 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2019 | Year | 08 | Month | 31 | Day |
Last modified on
| 2021 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043122
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
