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Clinical Trials/NCT00506506
NCT00506506
Completed
Phase 3

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

Lawson Health Research Institute1 site in 1 country60 target enrollmentOctober 2007

Overview

Phase
Phase 3
Intervention
N-acetylcysteine
Conditions
Chronic Kidney Disease
Sponsor
Lawson Health Research Institute
Enrollment
60
Locations
1
Primary Endpoint
24 hour creatinine clearance, estimated glomerular filtration rate (eGFR), proteinuria and cystatin C
Status
Completed
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2007
End Date
October 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

1

N-acetylcysteine 1200 mg twice daily x 48 hours

Intervention: N-acetylcysteine

2

Intervention: Placebo

Outcomes

Primary Outcomes

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

Study Sites (1)

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