UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030568 |
|---|---|
| Receipt number | R000034875 |
| Scientific Title | Efficacy and safety of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism inadequately controlled with cinacalcet |
| Date of disclosure of the study information | 2017/12/27 |
| Last modified on | 2022/06/30 11:57:32 |
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Basic information
Public title
Efficacy and safety of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism inadequately controlled with cinacalcet
Acronym
SWITCH Study
Scientific Title
Efficacy and safety of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism inadequately controlled with cinacalcet
Scientific Title:Acronym
SWITCH Study
Region
| Japan |
Condition
Condition
Secondary hyperparathyroidism
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy and safety of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism inadequately controlled with cinacalcet.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients with mean intact PTH levels during weeks 20-24 of 60-240 pg/ml.
Key secondary outcomes
Proportion of patients with >=30% reduction from baseline in mean intact PTH levels during weeks 20-24; changes from baseline in serum calcium, phosphorus, intact PTH, alkaline phosphatase, magnesium, and calcitonin; and adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Etelcalcetide
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
Intact PTH >=300 pg/ml
Receiving cinacalcet
Key exclusion criteria
Corrected serum calcium <8.4 mg/dL
Receiving hemodialysis less than three months
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Takahashi |
Organization
Jinken Clinic
Division name
Not applicable
Zip code
243-0432
Address
1-8-6 Chuo, Ebina, Kanagawa, 243-0432, Japan
TEL
046-231-8151
jinken@green.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Hiroo |
| Middle name | |
| Last name | Takahashi |
Organization
Jinken Clinic
Division name
Not applicable
Zip code
243-0432
Address
1-8-6 Chuo, Ebina, Kanagawa, 243-0432, Japan
TEL
046-231-8151
Homepage URL
htp911@cocoa.ocn.ne.jp
Sponsor or person
Institute
Jinken Clinic
Institute
Department
Personal name
Funding Source
Organization
Jinken Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokai University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Tokai University
Address
143 Shimo-Kasuya, Isehara, 259-1193, Japan
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.jp
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 | 12 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | 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 | 12 | Month | 26 | Day |
Last modified on
| 2022 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034875
