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

Chronic Kidney Disease Clinical Trial

Official title:

Randomized Controlled Trial Examining the Effect of N-Acetylcysteine on Serum Creatinine in Patients With Stage 3 Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506506
• Other study ID #: R-07-358
• Secondary ID: 13514
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2007
• Last updated: April 14, 2009
• Start date: October 2007
• Est. completion date: October 2008

Study information

• Verified date: April 2009
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• N-acetylcysteine
N-acetylcysteine 1200 mg twice daily x 48 hours
• Placebo

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour creatinine clearance, estimated glomerular filtration rate (eGFR), proteinuria and cystatin C