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

NCT01111422 | Unknown Phase 4

• 1 other identifier: Ewha 219-3-40
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

End-Stage Kidney Disease; Peritoneal Dialysis

Keywords

Antioxidant; Epithelial to Mesenchymal Transition; peritoneal fibrosis; Peritoneal Dialysis, Continuous Ambulatory

Outcome Measures

Primary Outcomes (1)

• Peritoneal membrane function

  Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test

  6 months

Secondary Outcomes (4)

• Oxydative stress status

  6 months

• Mesothelial cell transformation (Epithelial to Mesenchymal Transition)

  6 month

• Residual renal function

  6 month

• Peritoneal membrane function

  2 months

Study Arms (2)

Control

NO INTERVENTION

Age and sex matched peritoneal dialysis patients

N-acetylcysteine

EXPERIMENTAL

N-acetylcysteine in stable peritoneal dialysis patients

Drug: N-acetylcysteine

Interventions

N-acetylcysteine DRUG

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

Also known as: Muteran capsuleⓇ HAN WHA PHARM.

N-acetylcysteine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ewha Womans University: lead

Study Sites (1)

Ewha Womans University Mokdong Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Peritoneal Fibrosis

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Peritoneal Diseases; Digestive System Diseases; Fibrosis

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Duk-Hee Kang, MD. PhD.

  Ewha Womans University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mina Yu, MD

CONTACT

+82-2-2650-2562; yuelizabeth@hanmail.net

Hyun-Jung Kim, NR

CONTACT

+82-2-2650-5497; 40739@eumc.co.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 27, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: April 27, 2010

Record last verified: 2010-03

Locations

KR (1)