N Acetyl Cysteine for Cystinosis Patients

June 19, 2012 updated by: Maria Helena Vaisbich, University of Sao Paulo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Drug: N acetyl cysteine
N acetyl cysteine to cystinosis patients with CKD stages 1 to 4
Other Names:
  • N acety cysteine
Drug: N acetyl cysteine
N acetyl cysteine for cystinosis patients CKD stages 1 to 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change in creatinine clearance evaluated 6 months before , 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
change in cystatin C from baseline and after 3 months with NAC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Maria Helena Vaisbich, Doctor, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

May 19, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (ESTIMATE)

June 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cystinosis and NAC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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