UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049905 |
|---|---|
| Receipt number | R000056831 |
| Scientific Title | Database study on therapeutic drugs and prognosis in dialysis patients with changing times |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2024/01/09 10:27:07 |
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Basic information
Public title
Database study on therapeutic drugs and prognosis in dialysis patients with changing times
Acronym
Database study on therapeutic drugs and prognosis in dialysis patients
Scientific Title
Database study on therapeutic drugs and prognosis in dialysis patients with changing times
Scientific Title:Acronym
Database study on therapeutic drugs and prognosis in dialysis patients
Region
| Japan |
Condition
Condition
Hemodialysis patients with secondary hyperparathyroidism
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the treatment pattern of SHPT patients with changing the time.
To investigate the clinical outcome association from change the treatment pattern of SHPT patients.
Basic objectives2
Others
Basic objectives -Others
To investigate the practice patterns of CKD-MBD treatment, the treatment patterns inffection from new CKD-MBD drug or change of CKD-MBD guideline, the change in treatment pattern associated with clinical outcome
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the treatment pattern with change in the times.
1 Percentage of patients receiving the treatment.
2 Time to administration of the treatment.
3 Prescribed dose of the treatment.
･The treatment: Active Vitamin D, Calcimimetics.
Impact of differences in treatment policy on clinical outcome.
1 Incident of clinical outcome
2 Frequency of clinical outcome
3 Time to clinical outcome.
･clinical outcome :Treatment for shunt stenosis/occlusion(Percutaneous shunt dilation/Thrombectomy,etc),hospitalization with cardiac disease as a main factor,infection as the main factor,and fracture.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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 for whom 'artificial kidney' continuously is calculated for at least 6months
Patients with 'artificial kidney' calculated at intervals of 2 to 4 days at maximum
Patients who belong to institutions where provision of data to MDV persons has been started 3 month before the date of calculation of the first 'artificial kidney'
Patients with no record of hospitalization within 1 day before the date of the first 'artificial kidney"'calculation
Key exclusion criteria
None
Target sample size
7000
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Kawashima |
Organization
Ono Pharmaceutical Co.,ltd.
Division name
Department of Medical Affairs, Primary Medical Affairs Division
Zip code
541-8564
Address
8-2,Kyuutaromachi 1-chome, Chuo-ku osaka-shi, Osaka
TEL
06-6263-5670
m.kawashima@ono-pharma.com
Public contact
Name of contact person
| 1st name | Tamami |
| Middle name | |
| Last name | Ueno |
Organization
Ono Pharmaceutical Co., Ltd.
Division name
Section 4, Medical Affairs
Zip code
103-0023
Address
9-11, Nihonbashi-Hohcho 4-Chome, Chuo-ku, Tokyo 103-0023, Japan
TEL
03-5640-3701
Homepage URL
ta.ueno@ono-pharma.com
Sponsor or person
Institute
Ono Pharmaceutical Co.,ltd.
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co.,ltd.
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
Ono Pharmaceutical Co.,ltd.
Address
8-2,Kyuutaromachi1-chome,Chuo-ku, osaka-shi,Osaka
Tel
06-6263-5670
n.nishiwaki@ono-pharma.com
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
| 2022 | Year | 12 | Month | 28 | 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
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
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study uses the MDV database. The data is anonymized and no identifiable personal information is included in the database. Therefore, this study does not require approval by IRB.
Management information
Registered date
| 2022 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056831
| 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 |
