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

NCT ID: NCT00506506

Last Updated: 2009-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

N-acetylcysteine 1200 mg twice daily x 48 hours

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

N-acetylcysteine 1200 mg twice daily x 48 hours

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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N-acetylcysteine

N-acetylcysteine 1200 mg twice daily x 48 hours

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Lawson Health Research Institute

Principal Investigators

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Louise Moist, MD, MSC

Role: PRINCIPAL_INVESTIGATOR

Schulich School of Medicine and Dentistry, University of Western Ontario

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

References

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Moist L, Sontrop JM, Gallo K, Mainra R, Cutler M, Freeman D, House AA. Effect of N-acetylcysteine on serum creatinine and kidney function: results of a randomized controlled trial. Am J Kidney Dis. 2010 Oct;56(4):643-50. doi: 10.1053/j.ajkd.2010.03.028. Epub 2010 Jun 11.

Reference Type DERIVED
PMID: 20541301 (View on PubMed)

Other Identifiers

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13514

Identifier Type: -

Identifier Source: secondary_id

R-07-358

Identifier Type: -

Identifier Source: org_study_id

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