UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007862 |
|---|---|
| Receipt number | 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 09:34:23 |
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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
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
sadakenn@md.okayama-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
