Effect of N-Acetylcysteine (NAC) on Creatinine in Chronic Kidney Disease

Phase 3

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Placebo; Drug: N-acetylcysteine

• Registration Number: NCT00506506
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

N-acetylcysteine is used to reduce the risk of injury to the kidney after the administration of contrast dye. The mechanism and effectiveness of this intervention is not substantiated in the literature. The investigators hypothesize that serum creatinine will be lower in patients who receive NAC compared to those who receive the placebo but serum cystatin C will not change in patients who receive NAC compared to those who receive the placebo. Also urine creatinine will increase after the administration of NAC compared to before the administration of NAC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-20
• Study First Submitted QC: 2007-07-23
• Study First Posted: 2007-07-25
• Study Start: 2007-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-14
• Last Update Posted: 2009-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients with an eGFR between 30-60 ml/min calculated using last available creatinine and patient weight.
2. Age > 18
3. No known allergies to or adverse effects from NAC
4. No known scheduled radio-contrast procedures
5. No medications known to affect creatinine secretion

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	N-acetylcysteine	N-acetylcysteine 1200 mg twice daily x 48 hours

Primary Outcome Measures

Name	Time	Method
24 hour creatinine clearance, estimated glomerular filtration rate (eGFR), proteinuria and cystatin C

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada