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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025804
Receipt No. R000029654
Scientific Title Difference of plasma carnitine levels after at IV infusion and oral carnitine preparation administration and the stopping dosage
Date of disclosure of the study information 2017/01/23
Last modified on 2017/08/14

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Basic information
Public title Difference of plasma carnitine levels after at IV infusion and oral carnitine preparation administration and the stopping dosage
Acronym Carnitine Metabolism in Patients on Hemodialysis
Scientific Title Difference of plasma carnitine levels after at IV infusion and oral carnitine preparation administration and the stopping dosage
Scientific Title:Acronym Carnitine Metabolism in Patients on Hemodialysis
Region
Japan

Condition
Condition End stage kidney disease on HD
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Difference of plasma carnitine levels after at IV infusion and oral carnitine preparation administration and the stopping dosage
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes plasma concentrations of total carnitine(TC),acyl carnitine(AC),free carnitine(FC),and acyl/free carnitine ratio(AC/FC)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Change of dosing route of carnitine from P.O. to IV.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria None
Key exclusion criteria None
Target sample size 17

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirokazu Osawa
Organization Hakujikai jin clinic
Division name Dep.of Nephrology
Zip code
Address 5-5-18,Shikahama,Adachi-ku,Tokyo,123-0864
TEL 03-3856-7011
Email oosawa@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayoshi Nakata
Organization Hakujikai jin clinic
Division name Dep.of Nephrology
Zip code
Address 5-5-18,Shikahama,Adachi-ku,Tokyo,123-0864
TEL 03-3856-7011
Homepage URL
Email jincli@hakujikai.org

Sponsor
Institute Hakujikai jin clinic
Institute
Department

Funding Source
Organization None
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
Email

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 博慈会腎クリニック(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 23 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
Plasma concentrations of TC,FC,and AC at the beginning of the study were not statistically different between different dosing amounts although it was higher in the group administered 900mg/day.

TC,FC,AC levels significantly increased after three months upon switching to intravenous administration(TC,FC,AC:p<0.0001),but there was no significant difference in AC/FC during the observation period(p=0.1739).

After discontinuation of carnitine administration,TC,FC,and AC levels before the dialysis significantly decreased over three months,and subsequently decreased slowly after the third month(p<0.0001).The average FC value was maintained at normal levels until nine months,but fell below normal values when measured at the 12th month.
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
2015 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
2017 Year 05 Month 31 Day
Date of closure to data entry
2017 Year 06 Month 30 Day
Date trial data considered complete
2017 Year 06 Month 30 Day
Date analysis concluded
2017 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 23 Day
Last modified on
2017 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029654

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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