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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033833
Receipt No. R000038497
Scientific Title Whether hybrid training during dialysis improve patient's physical function and inflammation and arteriosclerosis
Date of disclosure of the study information 2018/08/29
Last modified on 2018/08/21

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Basic information
Public title Whether hybrid training during dialysis improve patient's physical function and inflammation and arteriosclerosis
Acronym Carnitine deficiency is associated with decreased exercise activity in hemodialysis patients
Scientific Title Whether hybrid training during dialysis improve patient's physical function and inflammation and arteriosclerosis
Scientific Title:Acronym Carnitine deficiency is associated with decreased exercise activity in hemodialysis patients
Region
Japan

Condition
Condition hemodyalysis people
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Carnitine deficiency is common in hemodialysis patients and is associated with muscle atrophy in hemodialysis patients. Here we investigated whether carnitine levels could be one of the independent predictor for exercise capacity in these patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Exercise tolerance test
Key secondary outcomes Before exercise and after 3 months Grip strength time up Go test Lower limb muscle strength functional reach test Body composition measurement Thigh muscle area by MRI etc

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We administer to the patient levocarnitine 1000 mg/dose during every dialysis for 3 months and compare with the placebo group.
Interventions/Control_2 We administer to the patient levocarnitine 1000 mg/dose during every dialysis for 3 months and compare it with the exercise group.
Interventions/Control_3 We administer to the patient levocarnitine 1000 mg/dose during every dialysis for 3 months and compare with the hybrid exercise group.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients over the age of 20 years with end stage renal disease undergoing hemodialysis
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 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kei Fukami
Organization Kurume univercity
Division name nephrology division
Zip code
Address asahimachi kurumecity fukuokapurifacture
TEL 0942-31-7002
Email fukami@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junko Yano
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
Homepage URL
Email yano_junko@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 Other
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 08 Month 29 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
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2018 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 21 Day
Last modified on
2018 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038497

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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