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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name