N Acetyl Cysteine for Cystinosis Patients

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Maria Helena Vaisbich, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01614431
First received: May 19, 2012
Last updated: June 19, 2012
Last verified: June 2012

May 19, 2012
June 19, 2012
March 2011
January 2012   (final data collection date for primary outcome measure)
  • creatinine clearance [ Time Frame: change in creatinine clearance evaluated 6 months before , at baseline and after 3 months with NAC ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Cystinosis patients will be evaluated 6 months before and at baseline and after 3 months after the use of NAC
Same as current
Complete list of historical versions of study NCT01614431 on ClinicalTrials.gov Archive Site
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Not Provided
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N Acetyl Cysteine for Cystinosis Patients
N Acetyl Cysteine Can Decrease the Progression of Renal Disease in Cystinosis Patients

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

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Disease
  • Cystinosis
  • Drug: N acetyl cysteine
    N acetyl cysteine to cystinosis patients with CKD stages 1 to 4
    Other Name: N acety cysteine
  • Drug: N acetyl cysteine
    N acetyl cysteine for cystinosis patients CKD stages 1 to 4
    Other Name: N acetyl cysteine
Experimental: N acetyl cysteine
NAC will be given to cystinosis patients and we will observe the renal function status and a marker of oxidative stress (TBARS)
Interventions:
  • Drug: N acetyl cysteine
  • Drug: N acetyl cysteine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
May 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • cystinosis patients age under 18 years with good compliance to the treatment with Chronic Kidney Disease 1 to 4 according to KDOQI

Exclusion Criteria:

  • patients with CKD stage 5
Both
1 Year to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01614431
Cystinosis and NAC
Not Provided
Maria Helena Vaisbich, University of Sao Paulo
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Maria Helena Vaisbich, Doctor University of Sao Paulo
University of Sao Paulo
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP