CClinicalTrials.gg
CompletedNCT00506506Updated Apr 15, 2009

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

A Phase 3 interventional study of N-acetylcysteine and Placebo in Chronic Kidney Disease, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-04-15.

Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Chronic Kidney Disease

Keywords

  • N-acetylcysteine
  • Chronic kidney disease
  • eGFR
  • Cystatin C
  • proteinuria
  • Stage 3 chronic kidney disease
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
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Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    1

    N-acetylcysteine 1200 mg twice daily x 48 hours

    Drug: N-acetylcysteine

  • Placebo comparator
    2

    Drug: Placebo

Interventions

  • DrugN-acetylcysteine

    N-acetylcysteine 1200 mg twice daily x 48 hours

  • DrugPlacebo
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What researchers measure

Primary outcomes

  1. 24 hour creatinine clearance, estimated glomerular filtration rate (eGFR), proteinuria and cystatin C

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Study locations

1 site
  • London Health Sciences Centre
    London, Ontario N6A 5W9, Canada
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References and documents

Publications

  • Moist L, Sontrop JM, Gallo K, Mainra R, Cutler M, Freeman D, House AA. Effect of N-acetylcysteine on serum creatinine and kidney function: results of a randomized controlled trial. Am J Kidney Dis. 2010 Oct;56(4):643-50. doi: 10.1053/j.ajkd.2010.03.028. Epub 2010 Jun 11. PubMed 20541301 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00506506
Lead sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Collaborators
The Physicians' Services Incorporated Foundation
First posted
Jul 25, 2007
Start date
Oct 2007
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Apr 15, 2009

Study contacts

Louise Moist, MD, MSC
principal investigator · Schulich School of Medicine and Dentistry, University of Western Ontario

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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