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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039889
Receipt No. R000045493
Scientific Title Evaluation of the efficacy of romosozumab for hemodialysis patients with hemodialysis
Date of disclosure of the study information 2020/03/31
Last modified on 2021/09/20

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Basic information
Public title Evaluation of the efficacy of romosozumab for hemodialysis patients with hemodialysis
Acronym Evaluation of the efficacy of romosozumab for hemodialysis patients with hemodialysis
Scientific Title Evaluation of the efficacy of romosozumab for hemodialysis patients with hemodialysis
Scientific Title:Acronym Evaluation of the efficacy of romosozumab for hemodialysis patients with hemodialysis
Region
Japan

Condition
Condition osteoporosis
Classification by specialty
Endocrinology and Metabolism Nephrology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The subject is a dialysis patient with osteoporosis.
Observe patients receiving romosozumab for one year and evaluate bone density, vascular calcification, and bone metabolic markers before and after administration.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone mineral density at 12 months after treatment
Key secondary outcomes

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 Injections of romosozumab (at a dose of 210 mg) monthly for 12 months
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 Patients 20 years or older with chronic hemodialysis patients with osteoporosis who have not sufficiently improved osteoporosis even after standard treatment for 6 months or more.
Key exclusion criteria 1)Patients who are not receiving standard treatment for osteoporosis
2)Persons who are contraindicated in taking evenity or denosumab
3)Patients who have taken romosozumab or denosumab within 6 months
4)Hypocalcemia
5)Patients with severe liver dysfunction, heart dyfunction, malignant tumor
6)Patients who are judged by the investigator not to be eligible for drug administration.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Tomohiro
Middle name
Last name Saito
Organization Showa University School of Medicine
Division name Department of Medicine, Division of Nephrology
Zip code 142-8555
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 0337848000
Email saitou1986@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Tomohiro
Middle name
Last name Saito
Organization Showa University School of Medicine
Division name Department of Medicine, Division of Nephrology
Zip code 142-8555
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 0337848000
Homepage URL
Email saitou1986@med.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Ethics comittiee of Showa university
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
Tel 03-3784-8000
Email m-rinri@ofc.showa-u.ac.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

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 31 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 18
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
2020 Year 03 Month 20 Day
Date of IRB
2019 Year 07 Month 11 Day
Anticipated trial start date
2020 Year 03 Month 20 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 20 Day
Last modified on
2021 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045493

Research Plan
Registered date File name
2021/09/20 ②研究実施計画書 20190807最終版.pdf

Research case data specifications
Registered date File name
2021/09/20 dataset.pdf

Research case data
Registered date File name
2021/09/20 data.pdf


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