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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033514
Receipt No. R000038214
Scientific Title Switching test from cinalcalcet to etelcalcetide in secondary hyperpapathyroidism patients ongoing hemodialysis
Date of disclosure of the study information 2018/08/01
Last modified on 2018/07/25

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Basic information
Public title Switching test from cinalcalcet to etelcalcetide in secondary hyperpapathyroidism patients ongoing hemodialysis
Acronym Switching test from cinalcalcet to etelcalcetide
Scientific Title Switching test from cinalcalcet to etelcalcetide in secondary hyperpapathyroidism patients ongoing hemodialysis
Scientific Title:Acronym Switching test from cinalcalcet to etelcalcetide
Region
Japan

Condition
Condition Secondary hyperpapathyroidism
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy of etelcalcetide
Basic objectives2 Others
Basic objectives -Others Safety of etelcalcetide
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Noninferiority of etelcalcetide to cinacalcet on serum parathyroid hormone suppression after 12 months
Key secondary outcomes Evaluation of safety of etelcalcetide, especially including hypocalcemia

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 From the day after cinacalcet discontinuation, etelcalcetide was intravenously injected bolus three times a week for 12 months at the end of each dialysis. The initial dose for intravenous injection was 2.5 mg once in cases where the previous amount of cinacalcet is less than 25 mg, and 5 mg in case of 25 mg or more. Then the dose of etelcalcetide was adjusted so that parathyroid hormone was in the range of 60 to 240.
Interventions/Control_2 The dose of Cinacalcet was adjusted so that parathyroid hormone was in the range of 60 to 240 in the group of continuous administration of cinacalcet.
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
25 years-old <
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Three weekly hemodialysis patients of secondary hyperparathyroidism who are orally taking Cinacalcet.
Key exclusion criteria Patients with malignant tumors
Target sample size 52

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryoichi Miyazaki
Organization Fujita Memorial Hospital
Division name Department of Internal Medicine
Zip code
Address 4-15-7 Houei, Fukui City
TEL 0776-21-1277
Email ryoichi@mitene.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoichi Miyazaki
Organization Fujita Memorial Hospital
Division name Department of Internal Medicine
Zip code
Address 4-15-7 Houei, Fukui City
TEL 0776-21-1277
Homepage URL
Email ryoichi@mitene.or.jp

Sponsor
Institute Fujita Memorial Hospital, Department of Internal Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 藤田記念病院(福井県)

Other administrative information
Date of disclosure of the study information
2018 Year 08 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
Parathyroid hormone significantly decreased in the change group from cinacalcet to etelcalcetide after 12 months.
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
2017 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
2018 Year 09 Month 30 Day
Date trial data considered complete
2018 Year 09 Month 30 Day
Date analysis concluded
2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 07 Month 25 Day
Last modified on
2018 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038214

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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