UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027637 |
|---|---|
| Receipt number | 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 13:08:01 |
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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
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
fukami@med.kurume-u.ac.jp
Public contact
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
kaida_yuusuke@kurume-u.ac.jp
Sponsor or person
Institute
Division of Nephrology, Department of Medicine, Kurume University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031623
