UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033856
Receipt number R000038407
Scientific Title Switching from etelcalcetide to evocalcet in hemodialysis patients with secondary hyperparathyroidism
Date of disclosure of the study information 2018/09/01
Last modified on 2024/02/26 22:03:20

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Basic information

Public title

Switching from etelcalcetide to evocalcet in hemodialysis patients with secondary hyperparathyroidism

Acronym

Switching from etelcalcetide to evocalcet

Scientific Title

Switching from etelcalcetide to evocalcet in hemodialysis patients with secondary hyperparathyroidism

Scientific Title:Acronym

Switching from etelcalcetide to evocalcet

Region

Japan


Condition

Condition

Secondary hyperparathyroidism

Classification by specialty

Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the efficacy and safety of switching from etelcalcetide to evocalcet in hemodialysis patients with secondary hyperparathyroidism.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Proportion of patients with mean intact PTH levels during weeks 20-24 of 60-240 pg/ml.

Key secondary outcomes

Proportion of patients with >=30% reduction from baseline in mean intact PTH levels during weeks 20-24; changes from baseline in serum calcium, phosphorus, intact PTH, and alkaline phosphatase; and adverse events.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Evocalcet

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

Receiving etelcalcetide

Key exclusion criteria

Receiving hemodialysis less than three months

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yuichiro
Middle name
Last name Takahashi

Organization

Jinken Clinic

Division name

Not applicable

Zip code

243-0436

Address

15-1 Ohgimachi, Ebina, Kanagawa, 243-0436, Japan

TEL

046-231-8151

Email

jinken@green.ocn.ne.jp


Public contact

Name of contact person

1st name Hiroo
Middle name
Last name Takahashi

Organization

Jinken Clinic

Division name

Not applicable

Zip code

243-0436

Address

15-1 Ohgimachi, Ebina, Kanagawa, 243-0436, Japan

TEL

046-231-8151

Homepage URL


Email

htp911@cocoa.ocn.ne.jp


Sponsor or person

Institute

Jinken Clinic

Institute

Department

Personal name



Funding Source

Organization

Jinken Clinic

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tokai University School of Medicine

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research Ethics Committee, Tokai University School of Medicine

Address

143 Shimo-Kasuya, Isehara, Kanagawa, 259-1193, Japan

Tel

0463-93-1121

Email

tokai-rinsho@ml.tokai-u.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



Other administrative information

Date of disclosure of the study information

2018 Year 09 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

Enrolling by invitation

Date of protocol fixation

2018 Year 08 Month 03 Day

Date of IRB


Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 22 Day

Last modified on

2024 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038407


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name