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OpenTrials
Completed

NCT Number: NCT00498342

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

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.

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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 Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont /Fletcher Allen Health Care, Inc.

Burlington, Vermont, 05401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

N-acetylcysteine

Drug

Primary outcomes

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

    Time frame: 48 hours

Secondary outcomes

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

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • FlowMedic

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 10, 2007
Registry last updated
Feb 18, 2008

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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