UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029155 |
|---|---|
| Receipt number | R000032898 |
| Scientific Title | Intervention study to evaluate the efficacy of etelcalcetide and cinacalcet on bone and mineral disorders in hemodialysis patient. |
| Date of disclosure of the study information | 2017/10/08 |
| Last modified on | 2017/11/21 21:52:26 |
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Basic information
Public title
Intervention study to evaluate the efficacy of etelcalcetide and cinacalcet on bone and mineral disorders in hemodialysis patient.
Acronym
Study to evaluate the efficacy of eterlcalcetide and cinacalcet on bone and mineral disorders in hemodialysis patients.
Scientific Title
Intervention study to evaluate the efficacy of etelcalcetide and cinacalcet on bone and mineral disorders in hemodialysis patient.
Scientific Title:Acronym
Study to evaluate the efficacy of eterlcalcetide and cinacalcet on bone and mineral disorders in hemodialysis patients.
Region
| Japan |
Condition
Condition
Hemodialysis patients treated with cinacalcet for secondary hyperparathyroidism
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the effectiveness of etelcalcetide and cinacalcet in
the management of secondary hyperparathyroidism in haemodialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of change of the parathyroid hormone in after fore weeks.
Dosage of etelcalcetide.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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 dosge(1.25-15mg/ever hemodialysis session)
12 weeks
Interventions/Control_2
cinacalcet dosage (12.5-100mg/day)
12weeks
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient who taken cinacalcet(25mg or 50mg) with serum adjusted calcium more than 9mg/dl, serum phosphate less than 7mg/dl and intact parathyroid hormone levels more than 60pg/ml and less than 240pg/ml
Key exclusion criteria
The patient judged low adherence was and additionally.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toguchi Makoto |
Organization
Kawashima hospital
Division name
urology
Zip code
Address
1-39, Kitasakoichiban-chou, Tokushima-city, Tokushima
TEL
088-631-0110
toguchimakoto@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Toguchi |
Organization
Kawashima hospital
Division name
urology
Zip code
Address
1-39, Kitasakoichiban-chou, Tokushima-city, Tokushima
TEL
088-631-0110
Homepage URL
toguchimakoto@gmail.com
Sponsor or person
Institute
Kawashima hospital
Institute
Department
Personal name
Funding Source
Organization
kawashima hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokushima University hospital
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 | 10 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 02 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 15 | Day |
Last modified on
| 2017 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032898
