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Sponsors and Collaborators: |
University of Vermont FlowMedic |
Information provided by: | University of Vermont |
ClinicalTrials.gov Identifier: | NCT00498342 |
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 |
ChemIDplus related topics: | Acetylcysteine Creatinine |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease |
Study Start Date: | June 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 89 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Vermont | |||||
University of Vermont /Fletcher Allen Health Care, Inc. | |||||
Burlington, Vermont, United States, 05401 |
University of Vermont |
FlowMedic |
Principal Investigator: | Richard J Solomon, M.D. | University of Vermont/Fletcher Allen Health Care,Inc. |
Responsible Party: | University of Vermont ( Dr. Richard Solomon ) |
Study ID Numbers: | UVM07-205 |
First Received: | July 6, 2007 |
Last Updated: | February 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00498342 |
Health Authority: | United States: Institutional Review Board |
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