UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034645
Receipt number R000039496
Scientific Title Cinacalcet medication adherence at the time of alteration of ethelcalcitide from cinacalcet
Date of disclosure of the study information 2018/10/25
Last modified on 2020/02/26 14:57:54

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Basic information

Public title

Cinacalcet medication adherence at the time of alteration of ethelcalcitide from cinacalcet

Acronym

Cinacalcet medication adherence at the time of alteration of ethelcalcitide from cinacalcet

Scientific Title

Cinacalcet medication adherence at the time of alteration of ethelcalcitide from cinacalcet

Scientific Title:Acronym

Cinacalcet medication adherence at the time of alteration of ethelcalcitide from cinacalcet

Region

Japan


Condition

Condition

Chronic renal failure

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the cinacalcet medication adherence at the time of changing etelcalcetide from cinacalcet

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Difference in good cinacalcet medication adherence group and poor group divided by serum iPTH increase rate before and after cinacalcet withdrawal

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Hemodialysis patients with secondary hyperparathyroidism

Key exclusion criteria

Patients complicated with serious diseases such as cancer, hematological disorders, and liver cirrhosis

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Michio
Middle name
Last name Kuwahara

Organization

Saitama Tsukinomori Clinic

Division name

Nephrology

Zip code

339-0012

Address

366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan

TEL

048-792-1811

Email

kuwahara@k-naika-cl.jp


Public contact

Name of contact person

1st name Michio
Middle name
Last name Kuwahara

Organization

Saitama Tsukinomori Clinic

Division name

Nephrology

Zip code

339-0012

Address

366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan

TEL

048-792-1811

Homepage URL


Email

kuwahara@k-naika-cl.jp


Sponsor or person

Institute

Saitama Tsukinomori Clinic

Institute

Department

Personal name



Funding Source

Organization

Saitama Tsukinomori Clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the ethics committee of Saitama Tsukinomori Clinic

Address

366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan

Tel

0487921811

Email

hayama@k-naika-cl.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 10 Month 25 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

35

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

Completed

Date of protocol fixation

2018 Year 10 Month 23 Day

Date of IRB

2018 Year 10 Month 23 Day

Anticipated trial start date

2018 Year 10 Month 25 Day

Last follow-up date

2019 Year 02 Month 28 Day

Date of closure to data entry

2019 Year 03 Month 09 Day

Date trial data considered complete

2019 Year 03 Month 09 Day

Date analysis concluded

2019 Year 03 Month 09 Day


Other

Other related information

We investigated drug adherence of cinacalcet when changing from cinacalcet to etelcalcetide. By calculating the rate of increase in serum iPTH before and after withdrawal of cinacalcet, it was possible to evaluate whether the adherence to cinacalcet was good. The results were presented at a table discussion meeting held in Saitama City on April 10, 2019, as "The practice of Secondary hyperparathyroidism treatment".


Management information

Registered date

2018 Year 10 Month 25 Day

Last modified on

2020 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=R000039496


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name