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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00506506
Enrollment
60
Registered
2007-07-25
Start date
2007-10-31
Completion date
2008-10-31
Last updated
2009-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

N-acetylcysteine, Chronic kidney disease, eGFR, Cystatin C, proteinuria, Stage 3 chronic kidney disease

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.

Interventions

DRUGN-acetylcysteine

N-acetylcysteine 1200 mg twice daily x 48 hours

DRUGPlacebo

Sponsors

The Physicians' Services Incorporated Foundation
CollaboratorOTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
24 hour creatinine clearance, estimated glomerular filtration rate (eGFR), proteinuria and cystatin C

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026