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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032637
Receipt No. 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 2019/03/26

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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
Middle name
Last name Ashio Yoshimura
Organization Zenjinkai Shinyokohama Daiichi Clinic
Division name Division of Nephrology
Zip code
Address ShinyokohamaChitosekannkoBLG 8F,3-6-4 Shinyokohama,kouhoku-ku,Yokohama
TEL 045-477-3412
Email shinyokohd@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Ashio Yoshimura
Organization Zenjinkai Shinyokohama Daiichi Clinic
Division name Division of Nephrology
Zip code
Address ShinyokohamaChitosekannkoBLG 8F,3-6-4 Shinyokohama,kouhoku-ku,Yokohama
TEL 045-477-3412
Homepage URL
Email shinyokohd@gmail.com

Sponsor
Institute Zenjinkai Shinyokohama Daiichi Clinic
Division of Nephrology
Institute
Department

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
Address
Tel
Email

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
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
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
2019 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037217

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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