Effect of N-Acetylcysteine (NAC) on Creatinine in Chronic Kidney Disease
Information source: Lawson Health Research Institute
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease
Intervention: N-acetylcysteine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Lawson Health Research Institute Official(s) and/or principal investigator(s):
Louise Moist, MD, MSC, Principal Investigator, Affiliation: Schulich School of Medicine and Dentistry, University of Western Ontario
Overall contact:
Louise Moist, MD, MSc, Phone: 519-685-8211, Email: louise.moist@lhsc.on.ca
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.
Clinical Details
Official title: Randomized Controlled Trial Examining the Effect of N-Acetylcysteine on Serum Creatinine in Patients With Stage 3 Chronic Kidney Disease
Study design: Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: 24 hour creatinine clearance, estimated glomerular filtration rate (eGFR), proteinuria and cystatin C
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Louise Moist, MD, MSc, Phone: 519-685-8211, Email: louise.moist@lhsc.on.ca
London Health Sciences Centre, London, Ontario N6A 5W9, Canada
Additional Information
Starting date: October 2007
Last updated: July 22, 2008
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