Clinical Trial: N Acetyl Cysteine for Cystinosis Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: N Acetyl Cysteine Can Decrease the Progression of Renal Disease in Cystinosis Patients

Brief Summary: This study intends to verify the interference of N acetyl cysteine in the progression of chronic kidney disease in patients with Nephropathic Cystinosis.

Detailed Summary: Patients with Nephropathic Cystinosis have an increased oxidative stress and go to end-stage renal disease, even when all steps of the treatment are done. Therefore, this study is conducted to verify the interference of the stress oxidative in the progression of the renal disease with the use of an oxidant drug, N acetyl cysteine (NAC). The investigators selected patients with good compliance of the treatment. In these patients the investigators evaluate the serum creatinine, creatinine clearance estimated by Schwartz Formula, cystatin C and a marker of oxidative stress, TBARS ( thiobarbituric acid substances). The variables are analyzed 6 months before the introduction of NAC and the three months after NAC.
Sponsor: University of Sao Paulo

Current Primary Outcome:

  • creatinine clearance [ Time Frame: change in creatinine clearance evaluated 6 months before , at baseline and after 3 months with NAC ]
    creatinine clearance will be evaluate 6 months beforw and at baseline and after 3 months with NAC
  • cystatin c [ Time Frame: change in cystatin C from baseline and after 3 months with NAC ]
    Cystinosis patients will be evaluated 6 months before and at baseline and after 3 months after the use of NAC


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Sao Paulo

Dates:
Date Received: May 19, 2012
Date Started: March 2011
Date Completion:
Last Updated: June 19, 2012
Last Verified: June 2012