The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease
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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 |
- 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 ]
- 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) |
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 |
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| United States, Vermont | |
| University of Vermont /Fletcher Allen Health Care, Inc. | |
| Burlington, Vermont, United States, 05401 | |
| 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 Kidney Failure, 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 June 13, 2013