UMIN-CTR Clinical Trial

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
Institute	Saitama Tsukinomori Clinic
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039496