UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054865 |
|---|---|
| Receipt number | R000062685 |
| Scientific Title | A study of hemodialysis cases in which etelcalcetide was switched to upacicalcet |
| Date of disclosure of the study information | 2024/07/03 |
| Last modified on | 2025/08/21 17:35:41 |
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Basic information
Public title
A study of hemodialysis cases in which etelcalcetide was switched to upacicalcet
Acronym
A study of hemodialysis cases in which etelcalcetide was switched to upacicalcet
Scientific Title
A study of hemodialysis cases in which etelcalcetide was switched to upacicalcet
Scientific Title:Acronym
A study of hemodialysis cases in which etelcalcetide was switched to upacicalcet
Region
| Japan |
Condition
Condition
Secondary hyperparathyroidism
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects on various test values when switching from Etelcalcetide to Upacicalcet in secondary hyperparathyroidism patients.
Basic objectives2
Others
Basic objectives -Others
To investigate the effects on various test values when switching from Etelcalcetide to Upacicalcet in secondary hyperparathyroidism patients.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Corrected serum calcium levels, serum phosphorus levels, iPTH levels, dialysate calcium concentration, dosage of phosphate binders(mg/day), and dosage of Vitamin D preparation (Maxacalcitol)(ug/week)3months and 6months after swtiching, compared with those at the time of swithcing.
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
1) Patients who used Etelcalcetide for secondary hyperparathyroidism between May 2022 and June 2022 and switched to Upacicalcet
2) Patients who continued Upacicalcet for 6 months after switching to Upacicalcet and had test results obtained 6 months later
Key exclusion criteria
1) Patients who discontinued/withdrew UPA
2) Those who have refused to have their data used by opting out
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Sato |
Organization
Medical Corporation Foundation Meirikai Shin-Matsudo Central General Hospital
Division name
Division of Nephrology,Department of Internal Medicine
Zip code
270-0034
Address
380 Shin-Matsudo 1-chome, Matsudo City, Chiba Prefecture
TEL
047-345-1111
satou@db4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Sato |
Organization
Medical Corporation Foundation Meirikai Shin-Matsudo Central General Hospital
Division name
Medical Corporation Foundation Meirikai Shin-Matsudo Central General Hospital
Zip code
270-0034
Address
380 Shin-Matsudo 1-chome, Matsudo City, Chiba Prefecture
TEL
047-345-1111
Homepage URL
satou@db4.so-net.ne.jp
Sponsor or person
Institute
Medical Corporation Foundation Meirikai Shin-Matsudo Central General Hospital
Institute
Department
Personal name
Funding Source
Organization
Sanwa Kagaku Research Institute 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
The clinical research ethical review board of Shido. Inc.
Address
614, 3-13-2 Kameari, Katsushika-ku, Tokyo
Tel
03-4500-5075
info@shido.co.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
（医）財団明理会新松戸中央総合病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://www.dustri.com/nc/article-response-page.html?artId=192304&doi=10.5414%2FCN111695
Number of participants that the trial has enrolled
37
Results
In the treatment of SHPT in hemodialysis patients, the serum corrected Ca level remained unchanged six months after switching from etelcalcetide to upacicalcet; however, a decrease in serum P levels and an increase in iPTH levels were observed. The reduction in the dose of maxacalcitol is thought to have contributed to the decrease in serum P levels. Switching from etelcalcetide to upacicalcet was considered to be a useful option particularly from the perspective of P control.
Results date posted
| 2025 | Year | 06 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 08 | Month | 20 | Day |
Baseline Characteristics
Patients who met all of the following criteria were included in this study:Hemodialysis patients with SHPT who used etelcalcetide from May 2022 to June 2022 and who switched to upacicalcet,Patients who continued upacicalcet for six months after switching to upacicalcet and for whom the blood test values at six months have been obtained.No washout period was provided for switching from etelcalcetide to upacicalcet.Patients who met any of the following criteria were excluded from this study:Patients who discontinued treatment with upacicalcet,Patients who refused the use of data through the opt-out policy
Participant flow
This study was a single-center retrospective study conducted in Japan. Only existing data were included in the analysis, and no new data were collected. The opt-out policy was adopted for the use of the existing data.
Adverse events
N/A
Outcome measures
The endpoints were set as the serum levels of corrected Ca, P, iPTH at the time of switching from etelcalcetide to upacicalcet, and at three and six months after switching, as well as the mean dose of maxacalcitol/week before switching, at two to four months after switching, and four to six months after switching. An analysis was also conducted on the factors relating to the change in iPTH at six months after switching.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062685
