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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01111422
Recruitment Status : Unknown
Verified March 2010 by Ewha Womans University.
Recruitment status was:  Recruiting
First Posted : April 27, 2010
Last Update Posted : April 27, 2010
Information provided by:
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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

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 Name: Muteran capsuleⓇ HAN WHA PHARM.

Primary Outcome Measures :
  1. Peritoneal membrane function [ Time Frame: 6 months ]
    Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test

Secondary Outcome Measures :
  1. Oxydative stress status [ Time Frame: 6 months ]
    Measurement of oxydative stress status with plasma and RBC (GSH/GSSG, 8-OHdG)

  2. Mesothelial cell transformation (Epithelial to Mesenchymal Transition) [ Time Frame: 6 month ]
    Morphology was analysed with peritoneal dialysate isolated mesothelial cell

  3. Residual renal function [ Time Frame: 6 month ]
    Changes in residual renal function (ΔKt/Vurea, ΔeGFR)

  4. Peritoneal membrane function [ Time Frame: 2 months ]
    Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01111422

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Contact: Mina Yu, MD +82-2-2650-2562
Contact: Hyun-Jung Kim, NR +82-2-2650-5497

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Korea, Republic of
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of
Contact: Mina Yu, MD    +82-2-2650-2562   
Contact: Hyun Jung Kim, Nurse    +82-2-2650-5497      
Principal Investigator: Duk-Hee Kang, Professor         
Sponsors and Collaborators
Ewha Womans University
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Principal Investigator: Duk-Hee Kang, MD. PhD. Ewha Womans University

Additional Information:
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Responsible Party: Nephrology, Ewha Womans University Mokdong Hospital Identifier: NCT01111422    
Other Study ID Numbers: Ewha 219-3-40
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: April 27, 2010
Last Verified: March 2010
Keywords provided by Ewha Womans University:
Epithelial to Mesenchymal Transition
peritoneal fibrosis
Peritoneal Dialysis, Continuous Ambulatory
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs