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

Peritoneal Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01111422
• Other study ID #: Ewha 219-3-40
• Status: Recruiting
• Phase: Phase 4
• First received: April 23, 2010
• Last updated: April 26, 2010
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2010
• Source: Ewha Womans University
• Contact: Mina Yu, MD
• Phone: +82-2-2650-2562
• Email: yuelizabeth[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Peritoneal Dialysis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peritoneal membrane function	Changes in peritoneal membrane function (? D/Pcreatinine, ?D/Purea) with peritoneal equilibrium test	6 months	Yes
Secondary	Oxydative stress status	Measurement of oxydative stress status with plasma and RBC (GSH/GSSG, 8-OHdG)	6 months	Yes
Secondary	Mesothelial cell transformation (Epithelial to Mesenchymal Transition)	Morphology was analysed with peritoneal dialysate isolated mesothelial cell	6 month	No
Secondary	Residual renal function	Changes in residual renal function (?Kt/Vurea, ?eGFR)	6 month	No
Secondary	Peritoneal membrane function	Changes in peritoneal membrane function (? D/Pcreatinine, ?D/Purea) with peritoneal equilibrium test	2 months	Yes

External Links

•   Cell Transformation Control Laboratory