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

Sponsor

Ewha Womans University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01111422

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End-Stage Kidney Disease Peritoneal Dialysis	Drug: N-acetylcysteine	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2010

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: Control

Age and sex matched peritoneal dialysis patients

Experimental: N-acetylcysteine

N-acetylcysteine in stable peritoneal dialysis patients

Drug: N-acetylcysteine

N-acetylcysteine (200 mg/capsule) 1200 mg/day (600 mg bid) for 6 months

Other Names:

Muteran capsuleⓇ HAN WHA PHARM.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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