UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036862
Receipt number R000042006
Scientific Title Switching from cinacalcet to ebocalcet in secondary hyperparathyroidism patients during hemodialysis.
Date of disclosure of the study information 2019/07/01
Last modified on 2023/04/14 18:52:17

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Basic information

Public title

Switching from cinacalcet to ebocalcet in secondary hyperparathyroidism patients during hemodialysis.

Acronym

Switching from cinacalcet to ebocalcet

Scientific Title

Switching from cinacalcet to ebocalcet in secondary hyperparathyroidism patients during hemodialysis.

Scientific Title:Acronym

Switching from cinacalcet to ebocalcet

Region

Japan


Condition

Condition

Secondary hyperparathyroidism

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Noninferiority of ebocalcet to cinacalcet on serum parathyroid hormone suppression after 12 months

Basic objectives2

Others

Basic objectives -Others

Safety of ebocalcet

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Noninferiority of ebocalcet to cinacalcet on serum parathyroid hormone suppression after 12 months

Key secondary outcomes

Evaluation of safety of ebocalcet, especially including hypocalcemia


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Evocalcet was started with an initial dose of 1 mg / day orally on the day after cinacalcet discontinuation.
The amount of evocalcet was then adjusted so that parathyroid hormone was in the 60-240 range.

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

25 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

Three weekly hemodialysis patients of seconda ry hyperparathyroidism who are orally taking Cinacalcet.

Key exclusion criteria

Patients with malignant tumors

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Ryoichi
Middle name RYOICHI
Last name Miyazaki

Organization

Fujita Memorial Hospital

Division name

Department of Internal Medicine

Zip code

910-0004

Address

4-15-7, Houei, Fukui City

TEL

0776-21-1277

Email

ryoichi@mitene.or.jp


Public contact

Name of contact person

1st name Ryoichi
Middle name
Last name Miyazaki

Organization

Fujita Memorial Hospital

Division name

Department of Internal Medicine

Zip code

910-0004

Address

4-15-7, Houei, Fukui City

TEL

0776-21-1277

Homepage URL


Email

ryoichi@mitene.or.jp


Sponsor or person

Institute

Fujita Memorial Hospita, Department of Internal Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization

Fujita Memorial Hospital

Address

4-15-7, Houei, Fukui City

Tel

0776-21-1277

Email

ryoichi@mitene.or.jp


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

藤田記念病院(福井県)


Other administrative information

Date of disclosure of the study information

2019 Year 07 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

20

Results

After changing from cinacalcet to evocalcet, there was no change in parathyroid hormone around 11 months. There were no serious adverse events during the study.

Results date posted

2019 Year 05 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 10 Month 30 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2018 Year 03 Month 15 Day

Date of IRB

2018 Year 11 Month 09 Day

Anticipated trial start date

2018 Year 03 Month 31 Day

Last follow-up date

2019 Year 06 Month 11 Day

Date of closure to data entry

2019 Year 07 Month 01 Day

Date trial data considered complete

2019 Year 07 Month 01 Day

Date analysis concluded

2019 Year 07 Month 31 Day


Other

Other related information

Data analysis was completed. Submission was abandoned due to inadequate case assignment.


Management information

Registered date

2019 Year 05 Month 27 Day

Last modified on

2023 Year 04 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042006


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name