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

Phase 4

• Conditions: End-Stage Kidney Disease; Peritoneal Dialysis
• Interventions: Drug: N-acetylcysteine

• Registration Number: NCT01111422
• Lead Sponsor: Ewha Womans University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-03
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-26
• Last Update Submitted: 2010-04-26
• Study First Posted: 2010-04-27
• Last Update Posted: 2010-04-27
• Primary Completion: 2010-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-acetylcysteine	N-acetylcysteine	N-acetylcysteine in stable peritoneal dialysis patients

Primary Outcome Measures

Name	Time	Method
Peritoneal membrane function	6 months	Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of