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

This study has been completed.
Sponsor:
Collaborator:
FlowMedic
Information provided by:
University of Vermont
ClinicalTrials.gov Identifier:
NCT00498342
First received: July 6, 2007
Last updated: February 11, 2008
Last verified: July 2007
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Drug: N-acetylcysteine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Study Start Date: June 2007
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00498342

Locations
United States, Vermont
University of Vermont /Fletcher Allen Health Care, Inc.
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
FlowMedic
Investigators
Principal Investigator: Richard J Solomon, M.D. University of Vermont/Fletcher Allen Health Care,Inc.
  More Information

Publications:
Responsible Party: Dr. Richard Solomon, University of Vermont
ClinicalTrials.gov Identifier: NCT00498342     History of Changes
Other Study ID Numbers: UVM07-205
Study First Received: July 6, 2007
Last Updated: February 11, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on August 28, 2014