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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034155
Receipt No. R000038830
Scientific Title Efficacy of Etelcalcetide vs Cinacalcet in Hemodialyzed Patients with Secondary Hyperparathyroidism
Date of disclosure of the study information 2018/09/15
Last modified on 2018/09/15

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Basic information
Public title Efficacy of Etelcalcetide vs Cinacalcet in Hemodialyzed Patients with Secondary Hyperparathyroidism
Acronym Efficacy of Etelcalcetide vs Cinacalcet in Hemodialyzed Patients with Secondary Hyperparathyroidism
Scientific Title Efficacy of Etelcalcetide vs Cinacalcet in Hemodialyzed Patients with Secondary Hyperparathyroidism
Scientific Title:Acronym Efficacy of Etelcalcetide vs Cinacalcet in Hemodialyzed Patients with Secondary Hyperparathyroidism
Region
Japan

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

Objectives
Narrative objectives1 To investigate the characteristics of etelcalcetide, etelcalcetide was administered to 50 hemodialysis outpatients at our hospital who were determined to require cinacalcet hydrochloride in accordance with The Clinical Practice Guideline for the Management of Chronic Kidney Disease-Mineral and Bone Disorder.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The endpoints were the levels of corrected serum calcium, serum phosphorus, intact PTH, tartrate-resistant acid phosphatase (TRACP)-5b, and bone-type alkaline phosphatase (BAP). The mean corrected serum calcium, serum phosphorus, and intact PTH levels for 24 weeks before the start of treatment with etelcalcetide (pre-treatment values) were compared with those for 24 weeks after the start of treatment (post-treatment values). The mean TRACP-5b and BAP levels at the start of treatment (pre-treatment values) with etelcalcetide were also compared with those for 24 weeks after the start of treatment (post-treatment values).
In addition, the endpoints were compared among treatment groups: cinacalcet hydrochloride-free group (n=8), low-dose cinacalcet hydrochloride/etelcalcetide group (switched from cinacalcet hydrochloride <26 mg/day to etelcalcetide; n=29), and high-dose cinacalcet hydrochloride/etelcalcetide group (switched from cinacalcet hydrochloride > 26 mg/day to etelcalcetide; n=13).
Key secondary outcomes Whether or not the mean corrected serum calcium level significantly differed between the 19 subjects who underwent a washout period and the 23 subjects who did not, after the start of treatment with etelcalcetide.


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

Not applicable
Gender Male and Female
Key inclusion criteria The subjects were hemodialysis outpatients at our hospital with high PTH levels and high or normal serum phosphorus or calcium levels. Therefore, according to the 9-section chart for maintaining optimal levels of serum phosphorus and calcium of the Clinical Practice Guideline for the Management of Chronic Kidney Disease-Mineral and Bone Disorder.
Key exclusion criteria Ineligible for the study as judged by the investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naofumi Ikeda
Organization Saitama Sekishinkai Hospital
Division name Department of Nephrology
Zip code
Address 2-37-20 Irumagawa, Sayama, Saitama, 350-1305,Japan
TEL 04-2953-6611
Email naofumi-ikeda@saitama-sekishinkai.org

Public contact
Name of contact person
1st name
Middle name
Last name Naofumi Ikeda
Organization Saitama Sekishinkai Hospital
Division name Department of Nephrology
Zip code
Address 2-37-20 Irumagawa, Sayama, Saitama, 350-1305,Japan
TEL 04-2953-6611
Homepage URL
Email naofumi-ikeda@saitama-sekishinkai.org

Sponsor
Institute Saitama Sekishinkai Hospital
Institute
Department

Funding Source
Organization Saitama Sekishinkai Hospital
Organization
Division
Category of Funding Organization Other
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
2018 Year 09 Month 15 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 Completed
Date of protocol fixation
2016 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 03 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 observation study

Management information
Registered date
2018 Year 09 Month 15 Day
Last modified on
2018 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038830

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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