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

Information source: Lawson Health Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease

Intervention: N-acetylcysteine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

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

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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

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

London Health Sciences Centre, London, Ontario N6A 5W9, Canada
Additional Information

Starting date: October 2007
Last updated: April 14, 2009

Page last updated: August 23, 2015

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