UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036862 |
|---|---|
| Receipt number | R000042006 |
| Scientific Title | Switching from cinacalcet to ebocalcet in secondary hyperparathyroidism patients during hemodialysis. |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2023/04/14 18:52:17 |
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Basic information
Public title
Switching from cinacalcet to ebocalcet in secondary hyperparathyroidism patients during hemodialysis.
Acronym
Switching from cinacalcet to ebocalcet
Scientific Title
Switching from cinacalcet to ebocalcet in secondary hyperparathyroidism patients during hemodialysis.
Scientific Title:Acronym
Switching from cinacalcet to ebocalcet
Region
| Japan |
Condition
Condition
Secondary hyperparathyroidism
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Noninferiority of ebocalcet to cinacalcet on serum parathyroid hormone suppression after 12 months
Basic objectives2
Others
Basic objectives -Others
Safety of ebocalcet
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Noninferiority of ebocalcet to cinacalcet on serum parathyroid hormone suppression after 12 months
Key secondary outcomes
Evaluation of safety of ebocalcet, especially including hypocalcemia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Evocalcet was started with an initial dose of 1 mg / day orally on the day after cinacalcet discontinuation.
The amount of evocalcet was then adjusted so that parathyroid hormone was in the 60-240 range.
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
| 25 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Three weekly hemodialysis patients of seconda ry hyperparathyroidism who are orally taking Cinacalcet.
Key exclusion criteria
Patients with malignant tumors
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | RYOICHI |
| Last name | Miyazaki |
Organization
Fujita Memorial Hospital
Division name
Department of Internal Medicine
Zip code
910-0004
Address
4-15-7, Houei, Fukui City
TEL
0776-21-1277
ryoichi@mitene.or.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Miyazaki |
Organization
Fujita Memorial Hospital
Division name
Department of Internal Medicine
Zip code
910-0004
Address
4-15-7, Houei, Fukui City
TEL
0776-21-1277
Homepage URL
ryoichi@mitene.or.jp
Sponsor or person
Institute
Fujita Memorial Hospita, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Fujita Memorial Hospital
Address
4-15-7, Houei, Fukui City
Tel
0776-21-1277
ryoichi@mitene.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
藤田記念病院（福井県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | 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
20
Results
After changing from cinacalcet to evocalcet, there was no change in parathyroid hormone around 11 months. There were no serious adverse events during the study.
Results date posted
| 2019 | Year | 05 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 10 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 11 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
Data analysis was completed. Submission was abandoned due to inadequate case assignment.
Management information
Registered date
| 2019 | Year | 05 | Month | 27 | Day |
Last modified on
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042006
