UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	On target management for secondary hyperparathyroidism by two calcimimetics (HP2C study)
Title of the study (Brief title)	HP2C study
Region	Japan

Condition
Condition	Chronic kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is the comparison of the effectiveness on the managements of PTH, Ca,and P between etelcalcetide and cinacalcet, and the impact of these drugs on other clinical parameters.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Achievement ratio for target levels of PTH, Ca, and P.
Key secondary outcomes	1) Bone metabolism marker. 2) Bone density. 3) Intestinal bacteria. 4) Arteriosclerosis index. 5) Drugs. 6) Anemia and iron-related factor. 7) The taking medicine situation. 8) Symptom. 9) Medical economic effect.

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	According to the clinical practice guideline for the management of chronic kidney disease-meneral and bone disease (JSDT 2012), treated with intravenous calcimimetics (etelcalcetide) for 1 year.
Interventions/Control_2	According to the clinical practice guideline for the management of chronic kidney disease-meneral and bone disease (JSDT 2012), treated oral calcimimetics (cinacalcet) for 1 year.
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	Maintenance hemodialysis patients with secondary hyperparathyroidism (int-PTH>240 pg/mL)
Key exclusion criteria	Patients with sever heart failure (>NYHA III),liver dysfunction, respiratory failure, and malignant tumor.
Target sample size	300

Research contact person
Name of lead principal investigator	Takeshi Nakanishi
Organization	Hyogo College of Medicine
Division name	Department of Internal Medicine, Division of Kidney and dialysis
Address	1-1, Mukogawa cho, Nishinomiyaya, Hyogo
TEL	0798-45-6521
Email	jin@hyo-med.ac.jp

Public contact
Name of contact person	Takahiro Kuragano
Organization	Hyogo College of Medicine
Division name	Department of Internal Medicine, Division of Kidney and dialysis
Address	1-1, Mukogawa cho, Nishinomiyaya, Hyogo
TEL	0798-45-6521
Homepage URL
Email	kuragano@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
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 10 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 05 Day
Anticipated trial start date	2017 Year 10 Month 01 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 09 Month 05 Day
Last modified on	2017 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033167