UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010953 |
|---|---|
| Receipt number | R000012820 |
| Scientific Title | Effects of L-carnitine on renal anemia in patients with CKD |
| Date of disclosure of the study information | 2013/06/13 |
| Last modified on | 2015/06/08 18:50:55 |
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Basic information
Public title
Effects of L-carnitine on renal anemia in patients with CKD
Acronym
Effects of L-carnitine on renal anemia in CKD patients
Scientific Title
Effects of L-carnitine on renal anemia in patients with CKD
Scientific Title:Acronym
Effects of L-carnitine on renal anemia in CKD patients
Region
| Japan |
Condition
Condition
CKD patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects L-carnitine on renal anemia, AGEs, general findings, and hypogonadism.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
improvement of anemia
Key secondary outcomes
improvement of AGEs, general findings, and hypogonadism
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
L-carnitine
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
CKD patients
Key exclusion criteria
1) severe infection
2) pregnancy
3) CHF, AKI
4) severe liver dysfunction
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Fukami |
Organization
Kurume University School of Medicine
Division name
Division of Nephrology, Department of Medicine,
Zip code
Address
67 Asahi-machi, Kurume city, Fukuoka
TEL
0942-35-3311
fukami@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Fukami |
Organization
Kurume University School of Medicine
Division name
Division of Nephrology, Department of Medicine,
Zip code
Address
67 Asahi-machi, Kurume city, Fukuoka
TEL
0942-35-3311
Homepage URL
fukami@med.kurume-u.ac.jp
Sponsor or person
Institute
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 06 | Month | 13 | 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
| 2012 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 08 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 07 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 14 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 13 | Day |
Last modified on
| 2015 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012820
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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