UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036702 |
|---|---|
| Receipt number | R000041815 |
| Scientific Title | Prescription change from cinacalcet hydrochloride to evocalcet in hemodialysis patients with secondary hyperparathyroidism |
| Date of disclosure of the study information | 2019/05/10 |
| Last modified on | 2019/11/11 10:17:18 |
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Basic information
Public title
Prescription change from cinacalcet hydrochloride to evocalcet in hemodialysis patients
Acronym
Switching from cinacalcet hydrochloride to evocalcet
Scientific Title
Prescription change from cinacalcet hydrochloride to evocalcet in hemodialysis patients with secondary hyperparathyroidism
Scientific Title:Acronym
Switching from cinacalcet hydrochloride to evocalcet in hemodialysis patients with SHPT
Region
| Japan |
Condition
Condition
Chronic hemodialysis patients with secondary hyperparathyroidism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influences of prescription change from cinacalcet hydrochloride (cinacalcet) to evocalcet on serum parameters in real world.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum parathyroid hormone (PTH) levels for 12 months after the switching.
Key secondary outcomes
Evocalcet dose
Serum corrected calcium levels
Serum phosphate levels
Serum alkaline phosphatase levels
Questionnaire on GI symptoms and medication adherence
Concomitant medication
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
Prescription change from cinacalcet hydrochloride (usual dose) to evocalcet (1 mg/day) and followed for 12 months.
Questionnaire on GI symptoms and medication adherence.
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Chronic hemodialysis patients treated with cinacalcet hydrochloride
Key exclusion criteria
Patients not treated with cinacalcet hydrochloride
Patients without informed consent
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Nagano |
Organization
Hidaka Hospital, Hidaka-kai
Division name
Kidney Disease and Dialysis Center
Zip code
370-0001
Address
886, Nakao-machi, Takasaki-shi, Gunma 370-0001, JAPAN
TEL
027-362-6201
n_nagano@hidaka-kai.com
Public contact
Name of contact person
| 1st name | Nobuo |
| Middle name | |
| Last name | Nagano |
Organization
Hidaka Hospital, Hidaka-kai
Division name
Kidney Disease and Dialysis Center
Zip code
370-0001
Address
886, Nakao-machi, Takasaki-shi, Gunma 370-0001, JAPAN
TEL
027-362-6201
Homepage URL
n_nagano@hidaka-kai.com
Sponsor or person
Institute
Kidney Disease and Dialysis Center, Hidaka Hospital, Hidaka-kai
Institute
Department
Personal name
Funding Source
Organization
Kidney Disease and Dialysis Center, Hidaka Hospital, Hidaka-kai
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Hidaka Hospital, Hidaka-kai
Address
886, Nakao-machi, Takasaki-shi, Gunma 370-0001, JAPAN
Tel
027-362-6201
renkei_2@hidaka-kai.com
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
日高病院、平成日高クリニック（群馬県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/browse/jsdt/-char/ja/
Number of participants that the trial has enrolled
147
Results
PTH increased for several months, while Ca transiently increased. The cinacalcet dose just before the switch was positively correlated with change in the amplitudes of PTH and Ca. The change in the amplitude of PTH was positively correlated with the change in the amplitude of Ca, suggesting that the transient Ca elevation was derived from the bone. Some patients stopped taking drugs that stimulate GI motility. The proportion of patients with GI symptoms decreased and medication adherence increased.
Results date posted
| 2019 | Year | 11 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 10 | Month | 28 | Day |
Baseline Characteristics
Participant flow
Adverse events
Hypocalcemia
Decreased serum PTH levels (<60 pg/mL)
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 10 | Day |
Last modified on
| 2019 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041815
