UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055838 |
|---|---|
| Receipt number | R000063817 |
| Scientific Title | A retrospective clinical study on the prognosis and incidence of fractures between calcimimetics users and non-users in patients on hemodialysis using dialyzers with beta2-microglobulin clearance of more than 70 mL/min and on online hemodialfiltration with achievement of PTH management target value |
| Date of disclosure of the study information | 2025/01/03 |
| Last modified on | 2025/01/03 04:01:59 |
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Basic information
Public title
A retrospective clinical study on the prognosis and incidence of fractures between calcimimetics users and non-users in dialysis patients with achievement of PTH management target value
Acronym
Influence of prognosis and fracture incidence between calcimimetics users and non-users in dialysis patients
Scientific Title
A retrospective clinical study on the prognosis and incidence of fractures between calcimimetics users and non-users in patients on hemodialysis using dialyzers with beta2-microglobulin clearance of more than 70 mL/min and on online hemodialfiltration with achievement of PTH management target value
Scientific Title:Acronym
Influence of prognosis and fracture incidence between calcimimetics users and non-users in HD using dialyzers with beta2-microglobulin clearance of more than 70 mL/min and OHDF
Region
| Japan |
Condition
Condition
Patients with end-stage kidney disease undergoing hemodialysis and online hemodiafiltration
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects on 2-year life prognosis and the incidence of fractures in patients with achievement of PTH target values (60 to 240pg/mL) will be compared between calcimimetics users and non-users.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2-year all-cause mortality
Key secondary outcomes
2-year incidence of fractures
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
Patients on maintenance hemodialysis or online hemodialysis as of July 1, 2017
Key exclusion criteria
1 Use of dialyzers with beta2-microgloburln clearance below 70 mL/min
2 Missing data for covariates at study entry
3 Dialysis conditionssuch as dialysis method and membrane material between April 1, 2017 and June 30, 2017, which are different from those as of July 1, 2017
4 Blood purification methods other than hemodialysis and online hemodiafiltration
5 Dialysis frequency below 3 sessions per week or dialysis time below 3 hour per session
6 Pregnant or lactating patients
7 Patients with below 60pg/mL or over PTH 241pg/mL
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Okada |
Organization
Social medical corporation Kawashimakai Kawashima Hospital
Division name
Blood purification management center
Zip code
7700011
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima, J
TEL
088-631-0110
kokada@minos.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Tashiro |
Organization
Social medical corporation Kawashimakai Kawashima Hospital
Division name
Department of Nephrology
Zip code
7700011
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima,Japan
TEL
0886310110
Homepage URL
m.tashiro@khg.or.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Kazuyoshi Okada
Funding Source
Organization
Nothing
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
Social medical corporation Kawashimakai Kawashima Hospital Research Ethics Committee
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima
Tel
088-631-0110
m.tashiro@khg.or.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 | 01 | Month | 03 | 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
425
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
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 11 | 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
A propensity score matching model will be used in a retrospective 2-year observational study to confirm the use of calcimimetics, PTH levels, hospital transfers, albumin leakage, and dialysate every year, and any changes between groups will be censored. The effects on 2-year life prognosis and the incidence of fractures in patients with achievement of PTH target values (60 to 240pg/mL) will be compared between calcimimetics users and non-users.
Management information
Registered date
| 2024 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063817
