UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of etelcalcetide and cinacalcet on bone mineral density in patients with secondary hyperparathyroidism
Title of the study (Brief title)	Effects of etelcalcetide and cinacalcet on bone mineral density
Region	Japan

Condition
Condition	Patients on hemodialysis complicated with secondary hyperparathyroidism
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of etelcalcetide and cinacalcet on bone mineral density.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bone mineral density (0, 6, 12 months) BAP, TRACP (0, 6, 12 months)
Key secondary outcomes	Ca, P, iPTH (once a month)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	etelcalcetide dosage (2.5 - 15mg/every hemodialysis session) 12 months
Interventions/Control_2	cinacalcet dosage (12.5 - 100mg/day) 12 months
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Maintenance hemodialysis patients with secondary hyperparathyroidism whose iPTH levels are higher than 240pg/ml despite the administration of maxacalcitol 2.5-5 micro g/every hemodialysis session.
Key exclusion criteria	Nothing paticular.
Target sample size	30

Research contact person
Name of lead principal investigator	Takahiro Yajima
Organization	Matsunami general hospital
Division name	Department of nephrology
Address	185-1, dendai, Kasamatsu-chou, Hashima-gun, Gifu
TEL	058-388-0111
Email	yajima5639@gmail.com

Public contact
Name of contact person	Takahiro Yajima
Organization	Matsunami general hospital
Division name	Department of Nephrology
Address	185-1, dendai, Kasamatsu-chou, Hashima-gun, Gifu
TEL	058-388-0111
Homepage URL
Email	yajima5639@gmail.com

Sponsor
Institute	Matsunami general hospital
Institute
Department

Funding Source
Organization	Matsunami general hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 05 Month 23 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 05 Month 15 Day
Anticipated trial start date	2017 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 23 Day
Last modified on	2017 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031333