The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease

Not Applicable

Completed

• Conditions: Chronic Kidney Disease

• Registration Number: NCT00498342
• Lead Sponsor: University of Vermont

Brief Summary

Primary outcome: Serum creatinine change at 4 hours and 48 hours following 4 doses of N-acetylcysteine (total 4800 mg) compared to baseline serum creatinine.

Secondary outcome: Serum Cystatin C change at 4 hours and 48 hours post 4 doses of N-acetylcysteine compared to baseline serum Cystatin C.

Detailed Description

N-acetylcysteine has been reported to lower serum creatinine in normal individuals. The mechanism of this effect is unknown but possible stimulation of tubular secretion of creatinine has been hypothesized based upon a lack of effect on Cystatin C levels. If this effect also occurs in subjects with chronic kidney disease, interpretation of clinical trials using N-acetylcysteine for prophylaxis of acute kidney injury would be confounded. To answer whether such confounding occurs, 50 patients with stable chronic kidney disease (Stage 3-5) will be given 4 doses of N-acetylcysteine, 1200 mg each, with measurement of serum creatinine and Cystatin C before, 4 hours and 48 hours after the last dose. No other interventions, including changes in medications, will be permitted during the study.

Study Timeline

• Study Start: 2007-06
• Status Verified: 2007-07
• Study First Submitted: 2007-07-06
• Study First Submitted QC: 2007-07-06
• Study First Posted: 2007-07-10
• Primary Completion: 2008-01
• Study Completion: 2008-02
• Last Update Submitted: 2008-02-11
• Last Update Posted: 2008-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Estimated GFR 10-59 ml/min/1.73m2 by 4 variable MDRD equation
• Less than a 10% difference between the baseline creatinine and the recruitment creatinine obtained within 3 months of the trial

Exclusion Criteria

• Unable to give informed consent
• Unwillingness to return for follow-up blood sampling
• Unstable renal function
• Subjects taking H2-blockers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Serum creatinine change at 4 hours and 48 hours following 4 doses of N-acetylcysteine (total 4800 mg) compared to baseline serum creatinine	48 hours

Secondary Outcome Measures

Name	Time	Method
Serum Cystatin C change at 4 hours and 48 hours post 4 doses of N-acetylcysteine compared to baseline serum Cystatin C	48 hours

Trial Locations

Locations (1)

University of Vermont /Fletcher Allen Health Care, Inc.; 🇺🇸 Burlington, Vermont, United States