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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Ewha Womans University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01111422
First Posted: April 27, 2010
Last Update Posted: April 27, 2010
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.
Information provided by:
Ewha Womans University
  Purpose
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 Intervention Phase
End-Stage Kidney Disease Peritoneal Dialysis Drug: N-acetylcysteine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ewha Womans University:

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


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

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

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

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


Estimated Enrollment: 66
Study Start Date: March 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01111422


Contacts
Contact: Mina Yu, MD +82-2-2650-2562 yuelizabeth@hanmail.net
Contact: Hyun-Jung Kim, NR +82-2-2650-5497 40739@eumc.co.kr

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

Additional Information:
Responsible Party: Nephrology, Ewha Womans University Mokdong Hospital
ClinicalTrials.gov Identifier: NCT01111422     History of Changes
Other Study ID Numbers: Ewha 219-3-40
First Submitted: April 23, 2010
First Posted: April 27, 2010
Last Update Posted: April 27, 2010
Last Verified: March 2010

Keywords provided by Ewha Womans University:
Antioxidant
Epithelial to Mesenchymal Transition
peritoneal fibrosis
Peritoneal Dialysis, Continuous Ambulatory

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes