ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00498342
Recruitment Status : Completed
First Posted : July 10, 2007
Last Update Posted : February 18, 2008
Sponsor:
Collaborator:
FlowMedic
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: N-acetylcysteine Not Applicable

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 Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease
Study Start Date : June 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Publications:
Responsible Party: Dr. Richard Solomon, University of Vermont
ClinicalTrials.gov Identifier: NCT00498342     History of Changes
Other Study ID Numbers: UVM07-205
First Posted: July 10, 2007    Key Record Dates
Last Update Posted: February 18, 2008
Last Verified: July 2007

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