UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040203 |
|---|---|
| Receipt number | 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 09:14:44 |
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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
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
fukami@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045845
| 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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