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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030354
Receipt No. R000034658
Scientific Title Evaluation of calcimimetic therapy in hemodialysis patients with secondary hyperparathyroidism: a real-world observational study
Date of disclosure of the study information 2017/12/11
Last modified on 2020/01/28

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Basic information
Public title Evaluation of calcimimetic therapy in hemodialysis patients with secondary hyperparathyroidism: a real-world observational study
Acronym ETERNAL Study
Scientific Title Evaluation of calcimimetic therapy in hemodialysis patients with secondary hyperparathyroidism: a real-world observational study
Scientific Title:Acronym ETERNAL Study
Region
Japan

Condition
Condition Hemodialysis patients with secondary hyperparathyroidism
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study evaluate all deaths and hospitalization due to cardiovascular events in hemodialysis patients with secondary hyperparathyroidism .
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Combined end-point of all deaths and hospitalization due to cardiovascular events
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients 20 years of age or older at the time of consent
2) Patients able to provide written consent themselves
3) Hemodialysis patients with secondary hyperparathyroidism who satisfy the following 3 conditions:
(1) Patients with an iPTH value of 300 pg/mL or above (wPTH of 177 pg/mL or above)
(2) Patients with a corrected calcium concentration of 9.0 mg/dL or above (ionized calcium of 2.25 mEq/L or above)
(3) Patients receiving active vitamin D therapy and not receiving calcimimetric treatment, as well as patients receiving cinacalcet
Key exclusion criteria 1) Patients with history of hemodialysis for less than 3 months at the time of eligibility confirmation
2) Patients who are inpatients at the time of eligibility confirmation
3) Patients who are planned to undergo surgery or be admitted to hospital at the time of eligibility confirmation where this will affect evaluation
4) Patients determined to be unsuitable for registration by the lead principal investigator or subinvestigator
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Okada
Organization Ono Pharmaceutical Co.,ltd.
Division name Department of Medical Affairs, Medical Planning II
Zip code
Address 8-2, Kyutaromachi 1-Chome, Chuo-ku, Osaka, 541-8564, JAPAN
TEL 06-6263-2992
Email eternal@ono.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomomi Imai
Organization Mebix Inc.
Division name Clinical Research Division
Zip code
Address Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo, Japan 107-0052
TEL 0120-956-411
Homepage URL
Email eternal-study@mebix.co.jp

Sponsor
Institute Ono Pharmaceutical Co.,ltd.
Institute
Department

Funding Source
Organization Ono Pharmaceutical Co.,ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2017 Year 12 Month 11 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 No longer recruiting
Date of protocol fixation
2017 Year 11 Month 01 Day
Date of IRB
2017 Year 11 Month 30 Day
Anticipated trial start date
2017 Year 12 Month 11 Day
Last follow-up date
2022 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information At present, etelcalcetide can be used as a new calcimimetic and the range of treatments has expanded, however the preventative effect of this drug on cardiovascular disease has not been sufficiently studied. Therefore, we decided to evaluate the long-term prognostic effect of etelcalcetide in an observational study on hemodialysis patients with secondary hyperparathyroidism and high PTH on existing treatment.

Management information
Registered date
2017 Year 12 Month 11 Day
Last modified on
2020 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034658

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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