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

This study has been completed.

First Received on July 20, 2007. Last Updated on April 14, 2009 History of Changes

Sponsor:	Lawson Health Research Institute
Collaborator:	The Physicians' Services Incorporated Foundation
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00506506

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 III

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:

MedlinePlus related topics: Kidney Failure

Drug Information available for: Creatinine Acetylcysteine

U.S. FDA Resources

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:

Patients with an eGFR between 30-60 ml/min calculated using last available creatinine and patient weight.
Age > 18
No known allergies to or adverse effects from NAC
No known scheduled radio-contrast procedures
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

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
Kidney Failure, Chronic
Renal Insufficiency, 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 February 09, 2012