UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033514 |
|---|---|
| Receipt number | R000038214 |
| Scientific Title | Switching test from cinalcalcet to etelcalcetide in secondary hyperpapathyroidism patients ongoing hemodialysis |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2023/04/14 18:51:09 |
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Basic information
Public title
Switching test from cinalcalcet to etelcalcetide in secondary hyperpapathyroidism patients ongoing hemodialysis
Acronym
Switching test from cinalcalcet to etelcalcetide
Scientific Title
Switching test from cinalcalcet to etelcalcetide in secondary hyperpapathyroidism patients ongoing hemodialysis
Scientific Title:Acronym
Switching test from cinalcalcet to etelcalcetide
Region
| Japan |
Condition
Condition
Secondary hyperpapathyroidism
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of etelcalcetide
Basic objectives2
Others
Basic objectives -Others
Safety of etelcalcetide
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Noninferiority of etelcalcetide to cinacalcet on serum parathyroid hormone suppression after 12 months
Key secondary outcomes
Evaluation of safety of etelcalcetide, especially including hypocalcemia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
From the day after cinacalcet discontinuation, etelcalcetide was intravenously injected bolus three times a week for 12 months at the end of each dialysis. The initial dose for intravenous injection was 2.5 mg once in cases where the previous amount of cinacalcet is less than 25 mg, and 5 mg in case of 25 mg or more. Then the dose of etelcalcetide was adjusted so that parathyroid hormone was in the range of 60 to 240.
Interventions/Control_2
The dose of Cinacalcet was adjusted so that parathyroid hormone was in the range of 60 to 240 in the group of continuous administration of cinacalcet.
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 secondary hyperparathyroidism who are orally taking Cinacalcet.
Key exclusion criteria
Patients with malignant tumors
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoichi Miyazaki |
Organization
Fujita Memorial Hospital
Division name
Department of Internal Medicine
Zip code
Address
4-15-7 Houei, Fukui City
TEL
0776-21-1277
ryoichi@mitene.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoichi Miyazaki |
Organization
Fujita Memorial Hospital
Division name
Department of Internal Medicine
Zip code
Address
4-15-7 Houei, Fukui City
TEL
0776-21-1277
Homepage URL
ryoichi@mitene.or.jp
Sponsor or person
Institute
Fujita Memorial Hospital, 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
Address
Tel
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
| 2018 | Year | 08 | 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
Results
Parathyroid hormone significantly decreased in the change group from cinacalcet to etelcalcetide after 12 months.
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
Terminated
Date of protocol fixation
| 2017 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 25 | 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=R000038214
