UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028041 |
|---|---|
| Receipt number | R000032106 |
| Scientific Title | The safety and efficacy of etelcalcetide for the treatment of secondary hyperparathyroidism compared with cinacalcet |
| Date of disclosure of the study information | 2017/07/02 |
| Last modified on | 2017/07/02 22:10:34 |
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Basic information
Public title
The safety and efficacy of etelcalcetide for the treatment of secondary hyperparathyroidism compared with cinacalcet
Acronym
The safety and efficacy of etelcalcetide compared with cinacalcet
Scientific Title
The safety and efficacy of etelcalcetide for the treatment of secondary hyperparathyroidism compared with cinacalcet
Scientific Title:Acronym
The safety and efficacy of etelcalcetide compared with cinacalcet
Region
| Japan |
Condition
Condition
Patients on maintenance hemodialysis treated with cinacalcet for secondary hyperparathyroidism
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the control of iPTH, Ca, P, the side effect, and the dosage of etelcalcetide and vitamin D, bone mineral density, vascular carcification when switching from cinacalcet to etelcalcetide
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
iPTH, Ca, P, side effect, dosage of etelcalcetide and vitamin D
Key secondary outcomes
Bone mineral density (0, 6, 12 months)
BAP, TRACP (0, 6, 12 months)
ABI and PWV, IMT (carotid ultrasound)
ACI and ACAI (abdominal CT) (0, 12 months)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
etelcalcetide dosage (2.5 - 15mg/every hemodialysis session)
12 months
Interventions/Control_2
cinacalcet dosage (12.5 - 100mg/day)
12 months
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with secondary hyperparathyroidism who are undergoing maintenance hemodialysis
Key exclusion criteria
Nothing
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Yajima |
Organization
Matsunami general hospital
Division name
Department of nephrology
Zip code
Address
185-1, dendai, Kasamatsu-chou, Hashima-gun, Gifu
TEL
058-388-0111
yajima5639@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Yajima |
Organization
Matsunami general hospital
Division name
Department of nephrology
Zip code
Address
185-1, dendai, Kasamatsu-chou, Hashima-gun, Gifu
TEL
058-388-0111
Homepage URL
yajima5639@gmail.com
Sponsor or person
Institute
Matsunami general hospital
Institute
Department
Personal name
Funding Source
Organization
Matsunami geneal hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 02 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 02 | Day |
Last modified on
| 2017 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032106
