UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025327 |
|---|---|
| Receipt number | R000029073 |
| Scientific Title | Efficacy and safety of levocarnitine injection therapy in dialysis patients with renal anemia |
| Date of disclosure of the study information | 2016/12/19 |
| Last modified on | 2020/02/12 09:01:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prevalence rate of carnitine and zinc deficiency and the efficacy of levocarnitine injection therapy in dialysis patients with renal anemia
Acronym
Effivavy of levocarnitine in patients with anemia
Scientific Title
Efficacy and safety of levocarnitine injection therapy in dialysis patients with renal anemia
Scientific Title:Acronym
Effivavy of levocarnitine in patients with anemia
Region
| Japan |
Condition
Condition
End-stage kidney disease undergoing hemodialysis or peritoneal dialysis with renal anemia.
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence rate of carnitine deficiency and the efficacy of levocarnitine for dialysis patients. Furthermore, we investigate the association with anemia-related factors, such as iron and zinc.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of carnitine deficincy, Physical function, lean body mass, BMI
Key secondary outcomes
Erythropoietin responsiveness index, Dose of erythropiesis stimulating agents, Hemoglobin, and zinc level
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1,000 mg dose of levocarnitine by injection three times a week after hemodialysis
Interventions/Control_2
Control (no levocarnitine therapy)
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) who received hemodialysis or peritoneal dialysis in our hospitals, (2) whose medical decisions were made at our hospitals, and (3) who were 20 to 85 years of age.
Key exclusion criteria
(1) patients who had previously taken levocarnitine, either orally or injected; (2) patients who were taking carnitine or zinc preparation as a supplement; (3) patients who have difficulty communicating owing to dementia or other factors; (4) patients with acute inflammation; (5) patients taking an immunosuppressive drug, steroid, or antibiotic; and (6) patients with a history of blood transfusion within the past six months.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Terumi Higuchi |
Organization
Keiai Hospital
Division name
Nephrology
Zip code
Address
3-10-23, Mukaihara, Itabashi-ku, Tokyo, Japan
TEL
03-3973-8111
thiguchi@keiai-hospital.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Terumi Higuchi |
Organization
Keiai Hospital
Division name
Nephrology
Zip code
Address
3-10-23, Mukaihara, Itabashi-ku, Tokyo, Japan
TEL
03-3973-8111
Homepage URL
thiguchi@keiai-hospital.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon 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
| 2016 | Year | 12 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 19 | Day |
Last modified on
| 2020 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029073
