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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027637
Receipt No. R000031623
Scientific Title The relationship of the effective dose and safety of cinacalcet hydrochloride and etelcalcetide hydrochloride in the Japanese patients with secondary hyperparathyroidism receiving hemodialysis, when switching cinacalcet hydrochloride to etelcalcetide hydrochloride.
Date of disclosure of the study information 2017/06/05
Last modified on 2019/03/13

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Basic information
Public title The relationship of the effective dose and safety of cinacalcet hydrochloride and etelcalcetide hydrochloride in the Japanese patients with secondary hyperparathyroidism receiving hemodialysis, when switching cinacalcet hydrochloride to etelcalcetide hydrochloride.
Acronym Evaluation of effective dose of cinacalcet hydrochloride and etelcalcetide hydrochloride
Scientific Title The relationship of the effective dose and safety of cinacalcet hydrochloride and etelcalcetide hydrochloride in the Japanese patients with secondary hyperparathyroidism receiving hemodialysis, when switching cinacalcet hydrochloride to etelcalcetide hydrochloride.
Scientific Title:Acronym Evaluation of effective dose of cinacalcet hydrochloride and etelcalcetide hydrochloride
Region
Japan

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

Objectives
Narrative objectives1 Evaluate the relationship of the effective dose and safety of cinacalcet hydrochloride and etelcalcetide hydrochloride in the Japanese patients with secondary hyperparathyroidism receiving hemodialysis, when switching cinacalcet hydrochloride to etelcalcetide hydrochloride.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dose distribution of etelcalcetide hydrochloride in patients achieved serum iPTH goal (60-240pg/mL) after 24 weeks of switching to etelcalcetide hydrochloride per cinacalcet hydrochloride treated group.
Key secondary outcomes - Dose distribution of etelcalcetide hydrochloride in patients achieved serum iPTH goal (60-240pg/mL) after 24 weeks of switching to etelcalcetide hydrochloride in the cinacalcet hydrochloride treated group with serum iPTH goal (60-240pg/mL).
- Chronological change amount and change rate of serum iPTH concentration from the start of study treatment.
- Chronological change amount and change rate of serum cCa concentration from the start of study treatment.
- Chronological change amount and change rate of serum P concentration from the study initiation.

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 Hydrochloride
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 1. Japanese patients with secondary hyperparathyroidism aged over 20 years old, receiving hemodialysis three times a week.
2. Treated with cinacalcet hydrochloride over 6 months (24 weeks), also administered with the fixed dosage of cinacalcet hydrochloride within three months before screening test.
3. Informed of etelcalcetide hydrochloride, and permitted the switch to etelcalcetide hydrochloride.
4. Patients not changed with the dosage and administration of phosphate binder (including calcium-containing phosphate binder), calcium preparations, and activated vitamin D preparations (oral, intravenous, derivative) within 14 days before screening test.
5. Patients not changed with dialysis procedure and hemodialysis machine (such as dialyzer, hemodialyzer) within 14 days before screening test.
6. Dialysis time is more than 4 hours, as well as hemodialysis dose(Kt/V) is more than 1.2 or urea reduction ratio(URR) is over 65 %.
7. Patients able to provide written informed consent for study participation.
Key exclusion criteria 1. Serum cCA is less than 8.4mg/dL at screening test.
2. Primary hyperparathyroidism
3. Plan to receive parathyroidectomy, parathyroid intervention, or kidney transplant during the study treatment.
4. Serum iPTH is less than 60 pg/mL
5. Poor medication compliance of cinacalcet hydrochloride (less than 50%)
6. Pregnant woman, or a woman who have possibility of pregnancy, wish to be pregnant, or lactating.
7. Others not inadequate judged by a physician.
Target sample size 120

Research contact person
Last name of lead principal investigator
1st name Kei
Middle name
Last name Fukami
Organization Kurume University
Division name Division of Nephrology, Department of Medicine
Zip code 830-0011
Address 67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL 0942-31-7002
Email fukami@med.kurume-u.ac.jp

Public contact
1st name of contact person
1st name Yusuke
Middle name
Last name Kaida
Organization Kurume University
Division name Division of Nephrology, Department of Medicine
Zip code 830-0011
Address 67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL 0942-31-7763
Homepage URL
Email kaida_yuusuke@kurume-u.ac.jp

Sponsor
Institute Division of Nephrology, Department of Medicine, Kurume University
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Network Fukuoka
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
Tel 092-643-7171
Email crnfcn@crnfukuoka.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 ・久留米大学病院 Kurume University Hospital
・杉循環器科内科病院 Sugi Cardiovascular Hospital
・医療法人 芳生会 和田内科・循環器科 Wada Cardiovascular Clinic
・医療法人みやざき 宮崎内科循環器内科 Miyazakinaika Medical Clinic
・医療法人 うすい内科・循環器科 Usui Clinic
・医療法人 慈香会 森山内科 Moriyama Clinic
・医療法人 清和会 長田病院 Nagata Hospital
・公立八女総合病院 Yame General Hospital
・社会福祉法人恩賜財団済生会支部 山口県済生会山口総合病院 yamaguchi saiseikai General Hospital
・医療法人 千葉内科循環器科 Chiba Naika Jyunkankika

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 05 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
2017 Year 04 Month 10 Day
Date of IRB
2017 Year 04 Month 24 Day
Anticipated trial start date
2017 Year 06 Month 05 Day
Last follow-up date
2018 Year 12 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 05 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031623

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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