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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034152
Receipt No. R000038931
Scientific Title Evaluation of the effect of L-carnitine administration on survival rates in chronic hemodialysis patients
Date of disclosure of the study information 2018/09/14
Last modified on 2018/09/14

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Basic information
Public title Evaluation of the effect of L-carnitine administration on survival rates in chronic hemodialysis patients
Acronym Effect of L- carnitine administration on survival rates in hemodialysis patients
Scientific Title Evaluation of the effect of L-carnitine administration on survival rates in chronic hemodialysis patients
Scientific Title:Acronym Effect of L- carnitine administration on survival rates in hemodialysis 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 survival rates in chronic hemodialysis 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 survival rates by administration of L-carnitine
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Patients over the age of 20 years with end stage renal disease undergoing hemodialysis
Key exclusion criteria Patients under the age of 20 years old

Patients undergoing combination therapy with peritoneal dialysis and hemodialysis

Others not inadequate judged by a physician
Target sample size 2500

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 0942-31-7763
Email fukami@med.kurume-u.ac.jp

Public contact
Name of contact person
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 0942-31-7763
Homepage URL
Email fukami@med.kurume-u.ac.jp

Sponsor
Institute Division of Nephrology, Department on Medicine, Kurume University
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 14 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
2018 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Survival rate of chronic hemodialysis patients by administration of L-carnitine

Management information
Registered date
2018 Year 09 Month 14 Day
Last modified on
2018 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038931

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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