N Acetyl Cysteine for Cystinosis Patients

Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614431
• Other study ID #: Cystinosis and NAC
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2012
• Last updated: June 19, 2012
• Start date: March 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystinosis
• Kidney Diseases
• Renal Disease

Intervention

Drug:
• N acetyl cysteine
N acetyl cysteine to cystinosis patients with CKD stages 1 to 4
• N acetyl cysteine
N acetyl cysteine for cystinosis patients CKD stages 1 to 4

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	creatinine clearance	creatinine clearance will be evaluate 6 months beforw and at baseline and after 3 months with NAC	change in creatinine clearance evaluated 6 months before , at baseline and after 3 months with NAC	Yes
Primary	cystatin c	Cystinosis patients will be evaluated 6 months before and at baseline and after 3 months after the use of NAC	change in cystatin C from baseline and after 3 months with NAC	Yes