UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034155 |
|---|---|
| Receipt number | 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 08:47:11 |
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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
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
naofumi-ikeda@saitama-sekishinkai.org
Sponsor or person
Institute
Saitama Sekishinkai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038830
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| Registered date | File name |
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