N Acetyl Cysteine for 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.

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Key information

Conditions

Renal Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystinosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Lysosomal Storage Diseases Male Urogenital Diseases Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

n acetyl cysteine

Drug

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

Other names: N acety cysteine

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jun 8, 2012
Registry last updated: Jun 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed