UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041834 |
|---|---|
| Receipt number | R000047721 |
| Scientific Title | ORKEDIA Tablets Special Drug Use Results Survey -Survey on Long-Term Treatment in Patients with Hemodialysis- |
| Date of disclosure of the study information | 2020/09/27 |
| Last modified on | 2021/09/30 17:05:51 |
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Basic information
Public title
ORKEDIA Tablets Special Drug Use Results Survey
-Survey on Long-Term Treatment in Patients with Hemodialysis-
Acronym
ORKEDIA Tablets Special Drug Use Results Survey
-Survey on Long-Term Treatment in Patients with Hemodialysis-
Scientific Title
ORKEDIA Tablets Special Drug Use Results Survey
-Survey on Long-Term Treatment in Patients with Hemodialysis-
Scientific Title:Acronym
ORKEDIA Tablets Special Drug Use Results Survey
-Survey on Long-Term Treatment in Patients with Hemodialysis-
Region
| Japan |
Condition
Condition
Secondary hyperparathyroidism (SHPT) on hemodialysis
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this survey is to verify the safety and efficacy of long-term treatment with Orkedia Tablets in the real-world in patients with secondary hyperparathyroidism (SHPT) on hemodialysis by conducting the following: (1) Detection of unknown adverse reactions, (2) Elucidation of the situations associated with the adverse reactions, (3) Identification of factors considered to affect the safety and efficacy, and (4) Investigation of safety specifications.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
1.Situation related to occurrence of adverse reactions or infections
2.Situation related to occurrence of serious adverse events
3.Investigation of safety specifications
4.Investigation of other adverse events(upper gastrointestinal tract disorders, opacity of the lens or cataract)
5.Identification of factors considered to affect safety
Efficacy
1.Time course of the concentrations of whole PTH, intact PTH, corrected serum Ca, serum P, corrected CaP product, and concentrations of serum ALP during the observation period
2.Efficacy rate based on the achievement of the concentrations of whole PTH, intact PTH, corrected serum Ca, and serum P in comparison with those in the guideline(note 1) during and after the observation period
3.Efficacy rate by background of patients
4.Identification of factors considered to affect the evaluation of efficacy
note 1)Clinical Practice Guideline for the Management of Chronic Kidney Disease-Mineral and Bone Disorder (Therapeutic Apheresis and Dialysis 2013 17(3) p247 to 288)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among patients with secondary hyperparathyroidism (SHPT) on hemodialysis, patients on hemodialysis who were naive to ORKEDIA(Evocalcet) were enrolled.
Key exclusion criteria
None
Target sample size
2400
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Takashima |
Organization
Kyowa Kirin Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
100-0004
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo, Japan
TEL
03-5205-7200
akira.takashima.jc@kyowakirin.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kuwazawa |
Organization
Kyowa Kirin Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
100-0004
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo, Japan
TEL
070-3143-9628
Homepage URL
hiroshi.kuwazawa.wd@kyowakirin.com
Sponsor or person
Institute
Kyowa Kirin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin 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
Research Ethical Review Committee of Kyowa Kirin Co., Ltd.
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo, Japan
Tel
03-5205-7202
researchethics.fj@kyowakirin.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
2542
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective surveillance
Management information
Registered date
| 2020 | Year | 09 | Month | 18 | Day |
Last modified on
| 2021 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047721
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
