UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031876
Receipt number R000036395
Scientific Title Effect of Lixelle to bone cyst: analysis by HR-pQCT
Date of disclosure of the study information 2018/03/24
Last modified on 2024/01/15 13:28:37

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Basic information

Public title

Effect of Lixelle to bone cyst: analysis by HR-pQCT

Acronym

Effect of Lixelle to bone cyst: analysis by HR-pQCT

Scientific Title

Effect of Lixelle to bone cyst: analysis by HR-pQCT

Scientific Title:Acronym

Effect of Lixelle to bone cyst: analysis by HR-pQCT

Region

Japan


Condition

Condition

dialysis amyloidosis

Classification by specialty

Endocrinology and Metabolism Nephrology Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze the effect of Lixelle to amyloid bone cyst by HR-pQCT

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

change of cyst volume

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

hemodialysis by Lixelle

Interventions/Control_2

conventional hemodialysis

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

HD>20years, carpal canal syndrome

Key exclusion criteria

treated by Denosmabu

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Osaki

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Orthopedic Surgery

Zip code

8528501

Address

1-7-1 Sakamoto, Nagasaki city, Nagasaki prefecture, Japan

TEL

095-819-7321

Email

kohchiba@estate.ocn.ne.jp


Public contact

Name of contact person

1st name Ko
Middle name
Last name Chiba

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Orthopedic Surgery

Zip code

8528501

Address

1-7-1 Sakamoto, Nagasaki city, Nagasaki prefecture, Japan

TEL

095-819-7321

Homepage URL


Email

kohchiba@estate.ocn.ne.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

Kaneka corporation

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

The Clinical Research Review Board in Nagasaki University

Address

1-7-1 Sakamoto, Nagasaki

Tel

095-819-7229

Email

gaibushikin@ml.nagasaki-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

2018 Year 03 Month 24 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

2018 Year 03 Month 24 Day

Date of IRB

2018 Year 03 Month 19 Day

Anticipated trial start date

2018 Year 05 Month 01 Day

Last follow-up date

2022 Year 12 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

2018 Year 03 Month 24 Day

Last modified on

2024 Year 01 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036395


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name