UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030354
Receipt number 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 2022/11/22 17:49:30

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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 being treated with an active vitamin D preparation alone, cinacalcet alone, or a combination of both

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 Masaru
Middle name
Last name Kawashima

Organization

Ono Pharmaceutical Co.,ltd.

Division name

Department of Medical Affairs, Primary Medical Affairs Division

Zip code

541-8564

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 Ami
Middle name
Last name Kitada

Organization

Mebix Inc.

Division name

Clinical Research Division

Zip code

107-0052

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 or person

Institute

Ono Pharmaceutical Co.,ltd.

Institute

Department

Personal name



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

Adachi Kyosai Hospital, ethics committee

Address

1-36-8, Yanagihara, Adachi-ku, Tokyo

Tel

03-3881-6116

Email

yama.chike2@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

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

2022 Year 11 Month 22 Day



Link to view the page

Value
https://center6.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