Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01614431 |
Date of registration:
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19/05/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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N Acetyl Cysteine for Cystinosis Patients
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Scientific title:
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N Acetyl Cysteine Can Decrease the Progression of Renal Disease in Cystinosis Patients |
Date of first enrolment:
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March 2011 |
Target sample size:
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23 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01614431 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Contacts
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Name:
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Maria Helena Vaisbich, Doctor |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Sao Paulo |
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Key inclusion & exclusion criteria
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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
Age minimum:
1 Year
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystinosis
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Renal Disease
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Intervention(s)
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Drug: N acetyl cysteine
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Primary Outcome(s)
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cystatin c
[Time Frame: change in cystatin C from baseline and after 3 months with NAC]
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creatinine clearance
[Time Frame: change in creatinine clearance evaluated 6 months before , at baseline and after 3 months with NAC]
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Secondary ID(s)
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Cystinosis and NAC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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