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

April 26, 2010 updated by: Ewha Womans University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Ewha Womans University Mokdong Hospital
        • Contact:
        • Contact:
          • Hyun Jung Kim, Nurse
          • Phone Number: +82-2-2650-5497
        • Principal Investigator:
          • Duk-Hee Kang, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University

Investigators

  • Principal Investigator: Duk-Hee Kang, MD. PhD., Ewha Womans University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2010

Study Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

April 23, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (ESTIMATE)

April 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 27, 2010

Last Update Submitted That Met QC Criteria

April 26, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ewha 219-3-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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