UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037330 |
|---|---|
| Receipt number | R000040459 |
| Scientific Title | Dose reduction of L-carnitine and serum carnitine concentration in hemodialysis patients |
| Date of disclosure of the study information | 2019/07/10 |
| Last modified on | 2021/06/07 15:47:34 |
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Basic information
Public title
Dose reduction of L-carnitine and serum carnitine concentration in hemodialysis patients
Acronym
Reduction of L-carnitine and concentration in HD patients
Scientific Title
Dose reduction of L-carnitine and serum carnitine concentration in hemodialysis patients
Scientific Title:Acronym
Reduction of L-carnitine and concentration in HD patients
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the carnitine concentration after reducing L-carnitine administration
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum carnitine levels
Key secondary outcomes
ERI, prevalence of clamp and fatigue, inflammation, oxidative stress, skin AGE levels, LVMI, EKG changes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
L-carnitine 1000mg 3 times/week for 6 months
Interventions/Control_2
L-carnitine 1000mg 1 time/week + salone 2 times/week for 6 months
Interventions/Control_3
saline 3 times/week for 6 months
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
HD patients
At least 3 months L-carnitine 1000mg 3times/week treatment
Patients who have stable
Patients whose Hb levels above 10g/dL
Key exclusion criteria
Symptoms are not stable.
Hb levels below 10g/dl
Target sample size
60
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-machi Kurume city Fukuoka, Japan
TEL
0942353311
fukami@med.kurume-u.ac.jp
Public contact
Name of contact person
| 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-machi Kurume city Fukuoka, Japan
TEL
0942353311
Homepage URL
fukami@med.kurume-u.ac.jp
Sponsor or person
Institute
Division of Nephrology, Department of Medicine
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Department of Medicine
Kurume University School of Medicine
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
Division of Nephrology, Department of Medicine Kurume University School of Medicine
Address
67 Asahi-machi, Kurume city Fukuoka Japan
Tel
0942353311
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
| 2019 | Year | 07 | Month | 10 | 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
| 2019 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 10 | Day |
Last modified on
| 2021 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040459
