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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029000
Receipt No. R000033167
Scientific Title On target management for secondary hyperparathyroidism by two calcimimetics (HP2C study)
Date of disclosure of the study information 2017/10/01
Last modified on 2017/09/05

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Basic information
Public title On target management for secondary hyperparathyroidism by two calcimimetics (HP2C study)
Acronym HP2C study
Scientific Title On target management for secondary hyperparathyroidism by two calcimimetics (HP2C study)
Scientific Title:Acronym 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
1st name
Middle name
Last name Takeshi Nakanishi
Organization Hyogo College of Medicine
Division name Department of Internal Medicine, Division of Kidney and dialysis
Zip code
Address 1-1, Mukogawa cho, Nishinomiyaya, Hyogo
TEL 0798-45-6521
Email jin@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Kuragano
Organization Hyogo College of Medicine
Division name Department of Internal Medicine, Division of Kidney and dialysis
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 05 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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