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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498342
• Other study ID #: UVM07-205
• Status: Completed
• Phase: N/A
• First received: July 6, 2007
• Last updated: February 11, 2008
• Start date: June 2007
• Est. completion date: February 2008

Study information

• Verified date: July 2007
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• N-acetylcysteine

Locations

Country	Name	City	State
United States	University of Vermont /Fletcher Allen Health Care, Inc.	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	FlowMedic

Country where clinical trial is conducted

United States, 

References & Publications (5)

Solomon R, Barrett B. Follow-up of patients with contrast-induced nephropathy. Kidney Int Suppl. 2006 Apr;(100):S46-50. — View Citation

Solomon R, Briguori C, Bettmann M. Selection of contrast media. Kidney Int Suppl. 2006 Apr;(100):S39-45. Review. Erratum in: Kidney Int Suppl. 2006 Dec;70(12):2156. Biguori, C [corrected to Briguori, C]. — View Citation

Solomon R, Deray G; Consensus Panel for CIN. How to prevent contrast-induced nephropathy and manage risk patients: practical recommendations. Kidney Int Suppl. 2006 Apr;(100):S51-3. — View Citation

Solomon R. Contrast media nephropathy--how to diagnose and how to prevent? Nephrol Dial Transplant. 2007 Jul;22(7):1812-5. Epub 2007 Apr 20. Review. — View Citation

Solomon RJ, Natarajan MK, Doucet S, Sharma SK, Staniloae CS, Katholi RE, Gelormini JL, Labinaz M, Moreyra AE; Investigators of the CARE Study. Cardiac Angiography in Renally Impaired Patients (CARE) study: a randomized double-blind trial of contrast-induced nephropathy in patients with chronic kidney disease. Circulation. 2007 Jun 26;115(25):3189-96. Epub 2007 Jun 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum creatinine change at 4 hours and 48 hours following 4 doses of N-acetylcysteine (total 4800 mg) compared to baseline serum creatinine		48 hours	No
Secondary	Serum Cystatin C change at 4 hours and 48 hours post 4 doses of N-acetylcysteine compared to baseline serum Cystatin C		48 hours	No