Unique ID issued by UMIN | UMIN000011760 |
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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 |
Effects of L-cysteine treatment on residual renal and peritoneal function in peritoneal dialysis patient
Effects of L-cysteine treatment in peritoneal dialysis patient
Effects of L-cysteine treatment on residual renal and peritoneal function in peritoneal dialysis patient
Effects of L-cysteine treatment in peritoneal dialysis patient
Japan |
end-stage renal failure
Nephrology |
Others
NO
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).
Efficacy
Confirmatory
Pragmatic
Phase I
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.
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.
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
Pseudo-randomization
2
Treatment
Medicine |
960 mg BID of orally L-cysteine is administrated for six-month
2 g BID of orally Lactate as placebo is administrated for six-month
18 | years-old | <= |
80 | years-old | >= |
Male and Female
peritoneal dialysis patients with residual renal function (over 400 ml/day urine volume)
peritoneal dialysis patients without any cancer or acute Inflammation
60
1st name | Akira |
Middle name | |
Last name | Tsuji |
National Defense Medical College Hospital
Department of Blood Purification
359-8513
3-2 Namiki, Tokorozawa Saitma, Japan
04-2995-1511
futebol@ndmc.ac.jp
1st name | Kaori |
Middle name | |
Last name | Ishizeki |
National Defense Medical College Hospital
Department of Blood Purification
359-8513
3-2 Namiki, Tokorozawa Saitma, Japan
04-2995-1511
halfmoon@ndmc.ac.jp
National Defense Medical College
Japanese Association of Dialysis Physicians
Non profit foundation
Japan
National Defense Medical College
3-2 Namiki, Tokorozawa Saitma, Japan
04-2995-1211
ins010@ndmc.ac.jp
NO
防衛医科大学校病院(埼玉県) National Defense Medical College Hospital (Saitama)
2013 | Year | 09 | Month | 14 | Day |
Unpublished
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.
Terminated
2009 | Year | 11 | Month | 09 | Day |
2010 | Year | 07 | Month | 06 | Day |
2014 | Year | 02 | Month | 28 | Day |
2014 | Year | 02 | Month | 28 | Day |
2014 | Year | 02 | Month | 28 | Day |
2014 | Year | 02 | Month | 28 | Day |
The number of cases necessary for this study is 60 cases in total.
However, we assumed this study cancellation because enrollment was 19 cases.
2013 | Year | 09 | Month | 13 | Day |
2019 | Year | 10 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013752
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