UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039961 |
|---|---|
| Receipt number | R000045558 |
| Scientific Title | Mineral and Bone Disorder-New EXecute Trial |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2024/04/03 15:00:11 |
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Basic information
Public title
Mineral and Bone Disorder-New EXecute Trial
Acronym
MBD-NEXT
Scientific Title
Mineral and Bone Disorder-New EXecute Trial
Scientific Title:Acronym
MBD-NEXT
Region
| Japan |
Condition
Condition
Hyperphosphatemia under maintenance hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study are to describe variations in patient profiles and practice patterns (pharmacotherapies, non-pharmacotherapies, dialysis treatment and laboratory data), and to analyze the causes of variation in practice patterns, and to identify practice patterns and other factors related to patient outcomes.
Basic objectives2
Others
Basic objectives -Others
1) Relationship between calcimimetics treatment and outcomes
2) Relationship between MBD parameters and outcomes
3) Relationship between calcimimetics treatment and MBD
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Mortality, cardiovascular mortality, hospitatization, lower limb intervention, anemia, vascular access, etc.
Key secondary outcomes
Laboratory data and PROs (patient reported 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
Maintenance hemodialysis patients who fulfill the following conditions
1) Patients who have given written informed consent
2) Patients with serum phosphate level of 3.5mg / dL or more or taking any phoshate binders.
Key exclusion criteria
Non
Target sample size
8400
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Fukagawa |
Organization
Japan chronic kidney disease - mineral bone disorder forum
Division name
Representative director
Zip code
259-1143
Address
143 Shimokasuya, Isehara-shi, Kanagawa
TEL
0463-93-1121
mbd.next.du@kyowakirin.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kirayama |
Organization
JAPAN CONVENTION SERVICES,INC
Division name
Medical Department
Zip code
100-0013
Address
1-4-2 kasumigaseki, Chiyoda-ku, Tokyo
TEL
03-3508-1214
Homepage URL
h-kira@convention.co.jp
Sponsor or person
Institute
Kyowa Kirin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute for Health Outcomes and Process Evaluation Research (iHope International)
Address
5-513, Akinono-cho, Nakagyo-ku, Kyoto
Tel
075-211-5656
research@i-hope.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
| 2020 | Year | 04 | Month | 01 | 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
8806
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Although we have completed data collection and cleaning, due to circumstances such as delays in registration and organizational changes related to this research, it has been decided that data analysis will not be conducted in this research. The database obtained in this research will be used for other research in the future, and this research will be terminated.
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
Terminated
Date of protocol fixation
| 2019 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 12 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 03 | Day |
Other
Other related information
The aims of this study are to describe variations in patient profiles and practice patterns (pharmacotherapies, non-pharmacotherapies, dialysis treatment and laboratory data), and to analyze the causes of variation in practice patterns, and to identify practice patterns and other factors related to patient outcomes.
Management information
Registered date
| 2020 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045558
