N Acetyl Cysteine for Cystinosis Patients

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01614431

Enrollment

Registered

2012-06-08

Start date

2011-03-31

Completion date

2012-05-31

Last updated

2012-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Disease, Cystinosis

Keywords

renal function, before and after N acetyl cysteine, 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 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.

Interventions

DRUGN acetyl cysteine

N acetyl cysteine to cystinosis patients with CKD stages 1 to 4

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026