UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011760
Receipt number R000013752
Scientific Title Effects of L-cysteine treatment on residual renal and peritoneal function in peritoneal dialysis patient
Date of disclosure of the study information 2013/09/14
Last modified on 2019/10/01 13:46:39

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Basic information

Public title

Effects of L-cysteine treatment on residual renal and peritoneal function in peritoneal dialysis patient

Acronym

Effects of L-cysteine treatment in peritoneal dialysis patient

Scientific Title

Effects of L-cysteine treatment on residual renal and peritoneal function in peritoneal dialysis patient

Scientific Title:Acronym

Effects of L-cysteine treatment in peritoneal dialysis patient

Region

Japan


Condition

Condition

end-stage renal failure

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Uremic patients are characterized by an imbalance between reactive oxygen species production and antioxidant defense, and increased inflammation and oxidative stress have been associated with cardiovascular disease. It is well documented that dialysis patients have low levels of glutathione. Glutathione is a major cellular antioxidant that protects protein thiols and inhibits cellular damage due to ROS. L-cysteine, a thiol-containing antioxidant, is stable in plasma and readily transported into cells, where is converted into glutathione. If L-cysteine improve the antioxidant status in peritoneal dialysis patients, L-cysteine may prevent cardiovascular disease. The current study aimed to determine the effect of six-month oral L-cysteine, a thiol-containing antioxidant, on these oxidative stress markers in peritoneal dialysis patients with residual renal function (over 400 ml/day urine volume).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

The primary endpoint of this study is the antioxidant effect by oral L-cysteine on peritoneal dialysis patients. Blood reduced glutathione/oxidized glutathione ratio, serum MDA-LDL and plasma homocysteine are measured after six-month oral L-cysteine treatment.

Key secondary outcomes

The secondary end point of this study is the preservation of residual renal function and peritoneal function by oral L-cysteine on peritoneal dialysis patients. Beta2-microglobulin and Cystatin C levels are measured after six-month oral L-cysteine treatment as residual renal function. Ay the same time, weekly urea Kt/V and creatinine clearance are assessed as peritoneal dialysis function.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

960 mg BID of orally L-cysteine is administrated for six-month

Interventions/Control_2

2 g BID of orally Lactate as placebo is administrated for six-month

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

18 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

peritoneal dialysis patients with residual renal function (over 400 ml/day urine volume)

Key exclusion criteria

peritoneal dialysis patients without any cancer or acute Inflammation

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Tsuji

Organization

National Defense Medical College Hospital

Division name

Department of Blood Purification

Zip code

359-8513

Address

3-2 Namiki, Tokorozawa Saitma, Japan

TEL

04-2995-1511

Email

futebol@ndmc.ac.jp


Public contact

Name of contact person

1st name Kaori
Middle name
Last name Ishizeki

Organization

National Defense Medical College Hospital

Division name

Department of Blood Purification

Zip code

359-8513

Address

3-2 Namiki, Tokorozawa Saitma, Japan

TEL

04-2995-1511

Homepage URL


Email

halfmoon@ndmc.ac.jp


Sponsor or person

Institute

National Defense Medical College

Institute

Department

Personal name



Funding Source

Organization

Japanese Association of Dialysis Physicians

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Defense Medical College

Address

3-2 Namiki, Tokorozawa Saitma, Japan

Tel

04-2995-1211

Email

ins010@ndmc.ac.jp


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

防衛医科大学校病院(埼玉県) National Defense Medical College Hospital (Saitama)


Other administrative information

Date of disclosure of the study information

2013 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

14th Congress of the International Society for Peritoneal Dialysis

Treatment with oral L-cysteine, which caused no side effects, significantly increased GSH/GSSG ratio from 1.63 to 4.80 (p<0.05) compared to placebo group (1.61 to 1.96). This intervention significantly decrease (p<0.05) both level of serum MDA-LDL (126.2 to 119.2 U/L) and plasma homocysteine (53.3 to 24.2 nmol/mL), whereas no such change was observed in placebo group (MDA-LDL; 113.5 to 134.8 U/L, homocysteine; 46.7 to 41.7 nmol/mL). Long-term oral L-cysteine treatment was effective to reduce both concentrations of serum MDA-LDL and plasma homocysteine with improvement of blood thiol-redox, with no side effects.

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

Terminated

Date of protocol fixation

2009 Year 11 Month 09 Day

Date of IRB


Anticipated trial start date

2010 Year 07 Month 06 Day

Last follow-up date

2014 Year 02 Month 28 Day

Date of closure to data entry

2014 Year 02 Month 28 Day

Date trial data considered complete

2014 Year 02 Month 28 Day

Date analysis concluded

2014 Year 02 Month 28 Day


Other

Other related information

The number of cases necessary for this study is 60 cases in total.
However, we assumed this study cancellation because enrollment was 19 cases.


Management information

Registered date

2013 Year 09 Month 13 Day

Last modified on

2019 Year 10 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013752


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name