UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000036702
Receipt No. 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 (Ver. 3)

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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
Email 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
Email n_nagano@hidaka-kai.com

Sponsor
Institute Kidney Disease and Dialysis Center, Hidaka Hospital, Hidaka-kai
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041815