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

NCT00506506 | Completed Phase 3

• 2 other identifiers: R-07-35813514
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease

Keywords

N-acetylcysteine; Chronic kidney disease; eGFR; Cystatin C; proteinuria; Stage 3 chronic kidney disease

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

1

EXPERIMENTAL

N-acetylcysteine 1200 mg twice daily x 48 hours

Drug: N-acetylcysteine

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

N-acetylcysteine DRUG

N-acetylcysteine 1200 mg twice daily x 48 hours

1

Placebo DRUG

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

• 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.

  PMID: 20541301 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Louise Moist, MD, MSC

  Schulich School of Medicine and Dentistry, University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2007
• First Posted: July 25, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 15, 2009

Record last verified: 2009-04

Locations

CA (1)