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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007862
Receipt No. R000008878
Scientific Title Development/validation of Outcome-based Prediction-tool for Survival in Patients after Initiation of Dialysis Treatment
Date of disclosure of the study information 2012/05/01
Last modified on 2015/06/24

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Basic information
Public title Development/validation of Outcome-based Prediction-tool for Survival in Patients after Initiation of Dialysis Treatment
Acronym Development of Prediction-tool for Survival in Dialysis Patients
Scientific Title Development/validation of Outcome-based Prediction-tool for Survival in Patients after Initiation of Dialysis Treatment
Scientific Title:Acronym Development of Prediction-tool for Survival in Dialysis Patients
Region
Japan

Condition
Condition Chronic Kidney Disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop and to validate a prediction tool for survival in patients after initiation of dialysis treatment
Basic objectives2 Others
Basic objectives -Others usefulness
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Survival after onset of end stage renal disease, eGFR 10 ml/min/1.73m2
Key secondary outcomes Duration between onset of dialysis-related complications and onset of end stage renal disease, eGFR 10 ml/min/1.73m2

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

Not applicable
Gender Male and Female
Key inclusion criteria Patient initiated dialysis from April 2006 to March 2011
Observed more than 1 year or reached endpoint
Date of reached eGFR 10 ml/min/1.73m2 were able to be detected
Key exclusion criteria Disagreement
Patient underwent transplantation
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken-ei Sada
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Medicine and Clinical Science
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL 086-235-7234
Email sadakenn@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sada Ken-ei
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Medicine and Clinical Science
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL 086-235-7234
Homepage URL
Email sadakenn@md.okayama-u.ac.jp

Sponsor
Institute Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Institute for Health Outcomes & Process Evaluation research
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 岡山大学(岡山県)、広島大学(広島県)、安城更生病院(愛知県)、新潟大学(新潟県)、帯広協会病院(北海道)、中部ろうさい病院(愛知県)、静岡県立総合病院(静岡県)、聖マリアンナ医科大学(神奈川県)、柏友千代田クリニック(大阪府)、昭和大学病院(東京都)、日野クリニック(大阪府)、虎の門病院分院(神奈川県)、高陵クリニック(富山県)、麻生飯塚病院(福岡県)、加美川クリニック(広島県)、久留米大学(福岡県)、東京女子医科大学(東京都)、京都大学(京都府)、国立病院機構熊本医療センター(熊本県)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0129180
Number of participants that the trial has enrolled
Results
A total of 688 patients were enrolled, and 62 (9.0%) patients died within one year of HD initiation. The following variables were retained in the final model: eGFR, serum albumin, calcium, Charlson Comorbidity Index excluding diabetes and renal disease (modified CCI), performance status (PS), and usage of erythropoiesis-stimulating agent (ESA). Their beta-coefficients were transformed into integer scores: three points were assigned to modified CCI>3 and PS 3-4; two to calcium>8.5 mg/dL, modified CCI 1-2, and no use of ESA; and one to albumin<3.5 g/dL, eGFR>7 mL/min per 1.73 m2, and PS 1-2. Predicted 1-year mortality risk was 2.5% (score 0-4), 5.5% (score 5-6), 15.2% (score 7-8), and 28.9% (score 9-12). The area under the receiver operating characteristic curve was 0.83 (95% confidence interval, 0.79-0.89).
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
2012 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2012 Year 07 Month 01 Day
Date of closure to data entry
2013 Year 06 Month 30 Day
Date trial data considered complete
2013 Year 09 Month 30 Day
Date analysis concluded
2014 Year 12 Month 31 Day

Other
Other related information Patients are randomly assigned to 2 subgroups. We develop the prognosis predictive scale considering lead-time bias based on clinical parameter at initiation of dialysis in one subgroup. After that we evaluated our prognosis predictive scale in another subgroup.

Management information
Registered date
2012 Year 04 Month 29 Day
Last modified on
2015 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008878

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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