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

Sponsor:	Ewha Womans University
Information provided by:	Ewha Womans University
ClinicalTrials.gov Identifier:	NCT01111422

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Antioxidants Dialysis Kidney Failure

Drug Information available for: Acetylcysteine

U.S. FDA Resources

Further study details as provided by Ewha Womans University:

Primary Outcome Measures:

Peritoneal membrane function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test

Secondary Outcome Measures:

Oxydative stress status [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Measurement of oxydative stress status with plasma and RBC (GSH/GSSG, 8-OHdG)
Mesothelial cell transformation (Epithelial to Mesenchymal Transition) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Morphology was analysed with peritoneal dialysate isolated mesothelial cell
Residual renal function [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Changes in residual renal function (ΔKt/Vurea, ΔeGFR)
Peritoneal membrane function [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Cell Transformation Control Laboratory This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Nephrology, Ewha Womans University Mokdong Hospital
ClinicalTrials.gov Identifier:	NCT01111422 History of Changes
Other Study ID Numbers:	Ewha 219-3-40
Study First Received:	April 23, 2010
Last Updated:	April 26, 2010
Health Authority:	Korea: Institutional Review Board

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
Antioxidants
Antiviral Agents
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on May 24, 2012