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Recruitment status Terminated
Unique ID issued by UMIN UMIN000011760
Receipt No. 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

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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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Middle name
Last name Tsuji
Organization National Defense Medical College Hospital
Division name Department of Blood Purification
Zip code
Address 3-2 Namiki, Tokorozawa Saitma, Japan
TEL 04-2995-1511
Email futebol@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ishizeki
Organization National Defense Medical College Hospital
Division name Department of Blood Purification
Zip code
Address 3-2 Namiki, Tokorozawa Saitma, Japan
TEL 04-2995-1511
Homepage URL
Email halfmoon@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013752


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