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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040203
Receipt No. R000045845
Scientific Title The screening of Fabry disease in male patients on dialysis and not on dialysis with chronic kidney disease in Japan
Date of disclosure of the study information 2020/04/20
Last modified on 2020/04/20

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Basic information
Public title The screening of Fabry disease in male patients on dialysis and not on dialysis with chronic kidney disease in Japan
Acronym The screening of Fabry disease in male patients on dialysis and not on dialysis with chronic kidney disease in Japan
Scientific Title The screening of Fabry disease in male patients on dialysis and not on dialysis with chronic kidney disease in Japan
Scientific Title:Acronym The screening of Fabry disease in male patients on dialysis and not on dialysis with chronic kidney disease in Japan
Region
Japan

Condition
Condition Male CKD patients
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Fabry disease (FD) is an X-linked lysosomal storage disorder caused by deficiency in alfa-galactosidase A (a-Gal A) activity due to mutations of alfa-galactosidase A (GLA) gene. Although the prevalence of FD has been reported to about 0.04 to 1.7% in hemodialysis patients, little is known in chronic kidney disease (CKD) patients not on dialysis (CKD-ND)
Basic objectives2 Others
Basic objectives -Others To examine the difference of the prevalence between CKD-ND and CKD-D
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prevalence of Fabry disease
Key secondary outcomes Comparison of the prevalence of FD between CKD-D and CKD-ND

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
Key inclusion criteria Male CKD patients
Key exclusion criteria Patients refuse the study inclusion.
Target sample size 3000

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

Public contact
Name of contact person
1st name Kei
Middle name
Last name Fukam
Organization Kurume University School of Medicine
Division name Division of Nephrology, Department of Medicine
Zip code 830-0011
Address 67 Asahi-machih Kurume city Fukuoka, Japan
TEL 0942-31-7002
Homepage URL
Email fukami@med.kurume-u.ac.jp

Sponsor
Institute Kurume University
Institute
Department

Funding Source
Organization no funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Division of Nephrology, Department of Medicine
Address 67 Asahi-machih Kurume city Fukuoka, Japan
Tel 0942-35-3311
Email fukami@med.kurume-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 医療法人 社団松下会 あけぼのクリニック      
医療法人 飯田クリニック              
医療法人 みらい 今立内科クリニック        
医療法人 社団如水会 今村病院           
医療法人 うすい内科・循環器科           
上村泌尿器科                    
大分県済生会日田病院                
地方独立行政法人 大牟田市立病院          
医療法人 春日医院                 
医療法人 豊資会 加野病院             
くるめ駅前クリニック                
公立八女総合病院                  
地方独立行政法人 下関市民病院           
医療法人 社団仁誠会 仁誠会クリニック大津     
医療法人 社団仁誠会 仁誠会クリニック黒髪     
医療法人 社団仁誠会 仁誠会クリニックながみね   
医療法人 社団仁誠会 仁誠会クリニック光の森    
医療法人 シーエムエス 杉循環器科内科病院     
医療法人 社会医療法人 雪の聖母会 聖マリア病院 
医療法人 社団高邦会 高木病院           
医療法人 聖峰会 田主丸中央病院          
医療法人 愛生会 外山内科             
医療法人 チクゴ医院                
医療法人 千葉内科循環器科             
医療法人 清和会 長田病院             
医療法人 健衆会 中野内科循環器科         
医療法人 緑の風 長沼医院             
医療法人 中村クリニック              
医療法人 福満会 ふくみつ病院           
まじま内科循環器科                 
松尾内科医院                    
医療法人 師天会 松岡内科クリニック        
医療法人 みやざき 宮崎内科循環器科        
医療法人 むとう内科クリニック           
医療法人 社団水光会 宗像水光会総合病院      
医療法人 村石循環器科・内科            
医療法人 慈香会 森山内科              
山下泌尿器科                    
医療法人 弘恵会 ヨコクラ病院           
医療法人 吉武泌尿器科医院             
医療法人 芳生会 和田内科循環器科         
独立行政法人 JCHO久留米総合病院          

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 20 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 2020
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
2009 Year 03 Month 28 Day
Date of IRB
2009 Year 04 Month 23 Day
Anticipated trial start date
2009 Year 04 Month 23 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The study was postponed at March 26, 2014.

Management information
Registered date
2020 Year 04 Month 20 Day
Last modified on
2020 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045845

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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