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

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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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name