UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034653 |
|---|---|
| Receipt number | R000039508 |
| Scientific Title | Differences in the effects of cinacalcet and ethelcalcetide from the mechanism of action |
| Date of disclosure of the study information | 2018/10/26 |
| Last modified on | 2020/02/26 14:24:45 |
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Basic information
Public title
Differences in the effects of cinacalcet and ethelcalcetide from the mechanism of action
Acronym
Differences in the effects of cinacalcet and ethelcalcetide from the mechanism of action
Scientific Title
Differences in the effects of cinacalcet and ethelcalcetide from the mechanism of action
Scientific Title:Acronym
Differences in the effects of cinacalcet and ethelcalcetide from the mechanism of action
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify differences in the effects of cinacalcet and etelcalcetide from the mechanism of action
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences between cinacalcet group and ethelcalcetide group by comparison of patient background, effect of Ca receptor agonist, and administered drugs
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients with secondary hyperparathyroidism
Key exclusion criteria
Patients complicated with serious diseases such as cancer, hematological disorders, and liver cirrhosis
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Kuwahara |
Organization
Saitama Tsukinomori Clinic
Division name
Nephrology
Zip code
339-0012
Address
366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
TEL
0487921811
kuwahara@k-naika-cl.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Kuwahara |
Organization
Saitama Tsukinomori Clinic
Division name
Nephrology
Zip code
339-0012
Address
366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
TEL
0487921811
Homepage URL
kuwahara@k-naika-cl.jp
Sponsor or person
Institute
Saitama Tsukinomori Clinic
Institute
Department
Personal name
Funding Source
Organization
Saitama Tsukinomori Clinic
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
the ethics committee of Saitama Tsukinomori Clinic
Address
366-1 Masunaga, Iwatsuki-ku, Saitama City, Saitama 339-0012, Japan
Tel
0487921811
hayama@k-naika-cl.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
| 2018 | Year | 10 | Month | 26 | 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
35
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
| 2018 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 12 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 12 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 12 | Day |
Other
Other related information
Cinacalcet and etelcalcetide have different sites of action on calcium-sensing receptors. Therefore, it was considered that the effects might be different, and a clinical study was conducted. However, there was no fundamental difference between the effects of the two agents. The results were announced at the Secondary hyperparathyroidism Medical Seminar held on November 7, 2019 in Ageo City, Saitama Prefecture.
Management information
Registered date
| 2018 | Year | 10 | Month | 26 | Day |
Last modified on
| 2020 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039508
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
