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

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00506506
First received: July 20, 2007
Last updated: April 14, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Drug: N-acetylcysteine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

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

Enrollment: 60
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Lawson Health Research Institute

Additional 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
Study First Received: July 20, 2007
Last Updated: April 14, 2009
Health Authority: Canada: Ethics Review Committee

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
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on April 17, 2014