Anti-Oxidant Effect on Peritoneal Membrane in Peritoneal Dialysis (PD) Patients

Study Overview
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Brief Summary
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Peritoneal fibrosis is one of the major causes of technical failure in patients on peritoneal dialysis (PD) for long period of time. Although the exact mechanisms of peritoneal damage during PD still remain unclear, generation of reactive oxygen species may be responsible for progressive membrane dysfunction. N-acetylcysteine (NAC)is a powerful antioxidant shown to protect peritoneal fibrosis in peritoneal dialysis animal model. In this study the researchers investigated the hypothesis that NAC protect peritoneal membrane damage.

Detailed Description
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N-Acetylcysteine (NAC) is known to be relatively safe and beneficial in peritoneal dialysis patient at a dose of 1200 mg per day. Patients will be randomly assigned to NAC and control group and prescribed according to the protocol. At 2 and 6 month, Peritoneal equilibrium test (PET) will be performed with blood sampling.

Official Title
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A Randomized Prospective Trial of N-acetyl Cystein in Patients With Peritoneal Dialysis

Conditions
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End-Stage Kidney Disease, Peritoneal Dialysis

Intervention / Treatment
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* Drug: N-acetylcysteine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Maintenance peritoneal dialysis at least 3 months Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information Exclusion Criteria: Episode of peritonitis at least 3 months Episodes of admission due to other disease at lease 3 months Liver disease Allergic history with N-acetylcysteine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Age and sex matched peritoneal dialysis patients | |
| Experimental: N-acetylcysteine<br>N-acetylcysteine in stable peritoneal dialysis patients | Drug: N-acetylcysteine<br>* N-acetylcysteine (200 mg/capsule) 1200 mg/day (600 mg bid) for 6 months<br>* Other names: Muteran capsuleⓇ HAN WHA PHARM.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peritoneal membrane function | Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxydative stress status | Measurement of oxydative stress status with plasma and RBC (GSH/GSSG, 8-OHdG) | 6 months | 
| Mesothelial cell transformation (Epithelial to Mesenchymal Transition) | Morphology was analysed with peritoneal dialysate isolated mesothelial cell | 6 month | 
| Residual renal function | Changes in residual renal function (ΔKt/Vurea, ΔeGFR) | 6 month | 
| Peritoneal membrane function | Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antioxidant, Epithelial to Mesenchymal Transition, peritoneal fibrosis, Peritoneal Dialysis, Continuous Ambulatory