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OpenTrials
Completed

NCT Number: NCT00506506

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteinuria Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetylcysteine

Drug

N-acetylcysteine 1200 mg twice daily x 48 hours

Placebo

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

Randomized Controlled Trial Examining the Effect of N-Acetylcysteine on Serum Creatinine in Patients With Stage 3 Chronic Kidney Disease

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 25, 2007
Registry last updated
Apr 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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