N Acetyl Cysteine for Cystinosis Patients

Phase 4

Completed

• Conditions: Renal Disease; Cystinosis
• Interventions: Drug: N acetyl cysteine

• Registration Number: NCT01614431
• Lead Sponsor: University of Sao Paulo

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-01
• Study Completion: 2012-05
• Study First Submitted: 2012-05-19
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-08
• Last Update Submitted: 2012-06-19
• Last Update Posted: 2012-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

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

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Exclusion Criteria

• patients with CKD stage 5

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
N acetyl cysteine	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)

Primary Outcome Measures

Name	Time	Method
creatinine clearance	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	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