UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010806 |
|---|---|
| Receipt number | R000012648 |
| Scientific Title | Prospective cohort study of patients on maintenace dialysis initiation |
| Date of disclosure of the study information | 2013/05/27 |
| Last modified on | 2026/02/02 15:49:53 |
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Basic information
Public title
Prospective cohort study of patients on maintenace dialysis initiation
Acronym
Ibaraki dialysis initiation cohort study (IDIC study)
Scientific Title
Prospective cohort study of patients on maintenace dialysis initiation
Scientific Title:Acronym
Ibaraki dialysis initiation cohort study (IDIC study)
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To study the relation between the clinical history and the outcome of patients on dialysis in Ibaraki.
2) To study the details of dialysis therapy initiation.
3) To study the predictive factors for prognosis of maintenance dialysis patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) The weaning from dialysis (patient mortality or renal transplantation)
2) Hospitalization for complications
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients requiring renal replacement therapy
Key exclusion criteria
Patients on temporary dialysis
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Yamagata |
Organization
Division of Clinical Medicine, Faculty of Medicine, University of Tsukuba
Division name
Department of Nephrology
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575
TEL
029-853-3202
kidney@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Joichi |
| Middle name | |
| Last name | Usui |
Organization
Division of Clinical Medicine, Faculty of Medicine, University of Tsukuba
Division name
Department of Nephrology
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575
TEL
029-853-3202
Homepage URL
j-usui@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Nephrology, Division of Clinical Medicine, Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Department of Nephrology, Division of Clinical Medicine, Faculty of Medicine, University of Tsukuba
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
University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
0298533900
kidney@md.tsukuba.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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35291986/
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35291986/
Number of participants that the trial has enrolled
636
Results
Results: A total of 636 patients were enrolled, including 424 men and 212 women. The mean age was 67.4 years, and the mean serum creatinine level was 9.1 mg/dL. The survival rates were 95.2% at 6 months and 87.7% at 2 years.
Results date posted
| 2026 | Year | 02 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 05 | Month | 15 | Day |
Baseline Characteristics
Sixty dialysis facilities in Ibaraki Prefecture participated, and patient enrollment was conducted from January 2013 to December 2014.
Participant flow
Sixty dialysis facilities in Ibaraki Prefecture participated
Adverse events
Not applicable
Outcome measures
Primary endpoint: 2-year survival rate after initiation of dialysis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | 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
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Finished
Management information
Registered date
| 2013 | Year | 05 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012648
