UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032637 |
|---|---|
| Receipt number | R000037217 |
| Scientific Title | Prospective study for effectiveness of Etelcalcetide hydrochloride (Parsabiv) on patients treated with hemodialysis |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2023/05/22 15:24:04 |
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Basic information
Public title
Prospective study for effectiveness of Etelcalcetide hydrochloride (Parsabiv) on patients treated with hemodialysis
Acronym
Prospective study for effectiveness of Etelcalcetide on dialysis patients
Scientific Title
Prospective study for effectiveness of Etelcalcetide hydrochloride (Parsabiv) on patients treated with hemodialysis
Scientific Title:Acronym
Prospective study for effectiveness of Etelcalcetide on dialysis patients
Region
| Japan |
Condition
Condition
patients treated with hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of PARSABIV on QOL of dialysis patients and on the development of complication are studied prospectively. Check of leftover medicine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Change of QOL (every month)
Key secondary outcomes
Estimation od complication (every month)
CTR/ECG (every month)
bone mineral density and UCG(1 year later)
General blood test (every month)
Check of leftover medicine
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients treating with hemodialysis for more than 12 months in dialysis clinic in Zenjinkai group
Key exclusion criteria
Patients decided as incompetent for this study by the doctor
Patietns showing contraindication for PARSABIV
Patients showing low Ca(<8.4) before admonistration of PARSABIV
Patients having malignant diseases
Patients having serious diseases in liver, kidney (other than CRF), and heart.
Patients treated with cinacalcet or bisphosphonate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ashio |
| Middle name | |
| Last name | Yoshimura |
Organization
Zenjinkai Shinyokohama Daiichi Clinic
Division name
Division of Nephrology
Zip code
222-0033
Address
ShinyokohamaChitosekannkoBLG 8F,3-6-4 Shinyokohama,kouhoku-ku,Yokohama
TEL
045-477-3412
shinyokohd@gmail.com
Public contact
Name of contact person
| 1st name | Ashio |
| Middle name | |
| Last name | Yoshimura |
Organization
Zenjinkai Shinyokohama Daiichi Clinic
Division name
Division of Nephrology
Zip code
222-0033
Address
ShinyokohamaChitosekannkoBLG 8F,3-6-4 Shinyokohama,kouhoku-ku,Yokohama
TEL
045-477-3412
Homepage URL
shinyokohd@gmail.com
Sponsor or person
Institute
Zenjinkai Shinyokohama Daiichi Clinic
Division of Nephrology
Institute
Department
Personal name
Ashio Yoshimura
Funding Source
Organization
Zenjinkai Shinyokohama Daiichi Clinic
Division of Nephrology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Yokohama Daiichi Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Zenjinkai Shinyokohama Daiichi Clinic
Address
ShinyokohamaChitosekannkoBLG 8F,3-6-4 Shinyokohama,kouhoku-ku,Yokohama
Tel
045-477-3412
shinyokohd@gmail.com
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 | 06 | Month | 01 | Day |
Related information
URL releasing protocol
The study has discontined.
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
20
Results
The study has discontinued.
Results date posted
| 2023 | Year | 05 | Month | 22 | Day |
Results Delayed
Results Delay Reason
The study has discontinued.
Date of the first journal publication of results
Baseline Characteristics
The study has discontinued.
Participant flow
The study has discontinued.
Adverse events
none
Outcome measures
The study has discontinued.
Plan to share IPD
The study has discontinued.
IPD sharing Plan description
The study has discontinued.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2018 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 31 | Day |
Other
Other related information
Change of QOL of patients after start of PARSABIV.
Blood chemistry including iPTH will be also
studied.
Management information
Registered date
| 2018 | Year | 05 | Month | 18 | Day |
Last modified on
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037217
| 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 |
