UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034152 |
|---|---|
| Receipt number | R000038931 |
| Scientific Title | Evaluation of the effect of L-carnitine administration on survival rates in chronic hemodialysis patients |
| Date of disclosure of the study information | 2018/09/14 |
| Last modified on | 2020/03/19 09:20:47 |
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Basic information
Public title
Evaluation of the effect of L-carnitine administration on survival rates in chronic hemodialysis patients
Acronym
Effect of L- carnitine administration on survival rates in hemodialysis patients
Scientific Title
Evaluation of the effect of L-carnitine administration on survival rates in chronic hemodialysis patients
Scientific Title:Acronym
Effect of L- carnitine administration on survival rates in hemodialysis patients
Region
| Japan |
Condition
Condition
Secondary carnitine deficiency
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of L-carnitine replacement therapy on survival rates in chronic hemodialysis patients with secondary carnitine deficiency
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of survival rates by administration of L-carnitine
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients over the age of 20 years with end stage renal disease undergoing hemodialysis
Key exclusion criteria
Patients under the age of 20 years old
Patients undergoing combination therapy with peritoneal dialysis and hemodialysis
Others not inadequate judged by a physician
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Fukami |
Organization
Kurume University
Division name
Division of Nephrology, Department on Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL
0942-31-7763
fukami@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Fukami |
Organization
Kurume University
Division name
Division of Nephrology, Department on Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL
0942-31-7763
Homepage URL
fukami@med.kurume-u.ac.jp
Sponsor or person
Institute
Division of Nephrology, Department on Medicine, Kurume University
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Department on Medicine, Kurume University
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
Kurume University
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
Tel
0942-31-7002
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 14 | 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
2000
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 | 09 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Survival rate of chronic hemodialysis patients by administration of L-carnitine
Management information
Registered date
| 2018 | Year | 09 | Month | 14 | Day |
Last modified on
| 2020 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038931
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
