UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031514 |
|---|---|
| Receipt number | R000035976 |
| Scientific Title | Evaluation of the effect of L-carnitine administration on peritoneal membrane function in peritoneal dialysis patients. |
| Date of disclosure of the study information | 2018/02/28 |
| Last modified on | 2019/03/01 13:08:17 |
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Basic information
Public title
Evaluation of the effect of L-carnitine administration on peritoneal membrane function in peritoneal dialysis patients.
Acronym
Effect of L- carnitine administration in peritoneal dialysis patients
Scientific Title
Evaluation of the effect of L-carnitine administration on peritoneal membrane function in peritoneal dialysis patients.
Scientific Title:Acronym
Effect of L- carnitine administration in peritoneal dialysis 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 peritoneal membrane function in peritoneal dialysis 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 peritoneal membrane function by administration of L-carnitine
Key secondary outcomes
Residual renal function
Cardiac function
Erythropoietin resistant anemia
Insulin resistance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Levocarnitine 750mg/day
Half a year
Interventions/Control_2
No treatment
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
1.Patients over the age of 20 years with end stage renal disease undergoing peritoneal dialysis
2.Patients able to provide written informed consent for study participation
Key exclusion criteria
1.Patients under the age of 20 years old
2.Patients who are contraindicated in the package insert of Levocarnitine
3.Patients undergoing combination therapy with peritoneal dialysis and hemodialysis
4.Pregnant woman, or a woman who have possibility of pregnancy
5.Others not inadequate judged by a physician
6.Patients who do not obtain consent
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Fukami |
Organization
Kurume University
Division name
Division of Nephrology, Department on Medicine
Zip code
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL
0942-31-7002
fukami@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakuya Ito |
Organization
Kurume University
Division name
Division of Nephrology, Department on Medicine
Zip code
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL
0942-31-7763
Homepage URL
itou_sakuya@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
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
久留米大学病院/Kurume University Hospital
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 28 | 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
| 2016 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 28 | 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
| 2018 | Year | 02 | Month | 28 | Day |
Last modified on
| 2019 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035976
