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

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ClinicalTrials.gov Identifier: NCT00506506
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : April 15, 2009
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: N-acetylcysteine Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Randomized Controlled Trial Examining the Effect of N-Acetylcysteine on Serum Creatinine in Patients With Stage 3 Chronic Kidney Disease
Study Start Date : October 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
N-acetylcysteine 1200 mg twice daily x 48 hours
Drug: N-acetylcysteine
N-acetylcysteine 1200 mg twice daily x 48 hours

Placebo Comparator: 2 Drug: Placebo



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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506506


Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Louise Moist, MD, MSC Schulich School of Medicine and Dentistry, University of Western Ontario

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. L. Moist, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00506506     History of Changes
Other Study ID Numbers: R-07-358
13514
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: April 15, 2009
Last Verified: April 2009

Keywords provided by Lawson Health Research Institute:
N-acetylcysteine
Chronic kidney disease
eGFR
Cystatin C
proteinuria
Stage 3 chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes