UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058721 |
|---|---|
| Receipt number | R000067133 |
| Scientific Title | "Incidence and Characteristics of Hypocalcemia after initiation or switching of calcimimetics" |
| Date of disclosure of the study information | 2025/08/08 |
| Last modified on | 2025/08/08 09:57:44 |
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Basic information
Public title
"Incidence and Characteristics of Hypocalcemia after initiation or switching of calcimimetics"
Acronym
"Incidence and Characteristics of Hypocalcemia after initiation or switching of calcimimetics"
Scientific Title
"Incidence and Characteristics of Hypocalcemia after initiation or switching of calcimimetics"
Scientific Title:Acronym
"Incidence and Characteristics of Hypocalcemia after initiation or switching of calcimimetics"
Region
| Japan |
Condition
Condition
Japanese Dialysis Patients with CKD-MBD
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the incidence of hypocalcemia among different calcimimetic formulations in dialysis patients with CKD-MBD. Additionally, we will describe the therapeutic interventions implemented following hypocalcemia and the subsequent course of recovery.
Basic objectives2
Others
Basic objectives -Others
Retrospective observational study based on existing data
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary outcome is the occurrence of hypocalcemia
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients attending a dialysis facility as outpatients who agree to participate in the study
Key exclusion criteria
Patients on peritoneal dialysis
Target sample size
8800
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Shimizu |
Organization
Institute for Health Outcomes & Process Evaluation Research
Division name
Research Division
Zip code
604-8006
Address
Shimomaruya-cho 403 Nakagyo-ku Kyoto-city Japan
TEL
075-555-3457
Shimizu@i-hope.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Kabaya |
Organization
Patient Driven Academic League
Division name
Administrative Division
Zip code
6040924
Address
537-20 Ichinofunairi-cho Nakagyo-ku Kyoto-city Japan
TEL
075-777-1261
Homepage URL
admin@pedal.or.jp
Sponsor or person
Institute
Patient Driven Academic League
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 & Process Evaluation Research
Address
Shimomaruya-cho 403 Nakagyo-ku Kyoto-city Japan
Tel
075-555-3457
kabaya@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
| 2025 | Year | 08 | Month | 08 | 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
8800
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data from observational studies were used; data were collected retrospectively from 2017 until the date consent was obtained. Prospective data collection after the date consent was obtained.
Management information
Registered date
| 2025 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067133
