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Detection of Fabry Disease in Chronic Renal Failure Patients in Area Provence - Alpes - Côte d'Azur

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01374997
First received: June 3, 2011
Last updated: July 7, 2011
Last verified: March 2011

June 3, 2011
July 7, 2011
June 2011
March 2012   (final data collection date for primary outcome measure)
Screening to detect of Fabry disease in chronic renal failure patients [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Screening will be conducted by a blood test to measure the level of alpha-galactosidase A activity by micromethod from samples taken from blood spots on filter paper. If this assay was positive, confirmation of diagnosis of Fabry disease will done the standard method: macrodosage of leukocytic alpha-galactosidase A activity.
Same as current
Complete list of historical versions of study NCT01374997 on ClinicalTrials.gov Archive Site
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Detection of Fabry Disease in Chronic Renal Failure Patients in Area Provence - Alpes - Côte d'Azur
Screening Project for a Detection of Fabry Disease in Chronic Renal Failure Patients in Area PACA

Fabry disease is a rare genetic disease characterized by an enzyme deficiency, called alpha-galactosidase A, which normally breaks down a lipid, is missing or does not function properly. As a result, the lipid accumulates in the body, this leads to multisystem impairment, including progressive renal failure.

Several studies have focused on the detection of this disease in end-stage renal failure patients, transplant or hemodialysis.

This study aims to diagnose the Fabry patients earlier, among men aged 18-60 years with a glomerular filtration rate estimated by MDRD between 60 and 15 ml/min/1, 73m2, or between 90 and 60 ml/min/1, 73m2 in association with proteinuria greater than 0.3 g / g or creatinine level greater than 0,5 g/l.

This screening will be conducted by a blood test to measure the level of alpha-galactosidase A activity by micromethod from samples taken from blood spots on filter paper. If this assay was positive, confirmation of diagnosis of Fabry disease will done the standard method: macrodosage of leukocytic alpha-galactosidase A activity.

This multicenter prospective study, openly contacted in medical practice, with patient follow-up corresponding to the management of renal insufficiency, will be offered to all departments of nephrology and dialysis for adults in the Provence - Alpes - Côte d'Azur.

The objective of this study is to assess the prevalence of Fabry disease in the target population and to identify previously undiagnosed patients, enabling them to benefit from appropriate management of their disease, including whether need enzyme replacement therapy.

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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Fabry Disease
Other: micromethod from samples taken from blood spots on filter paper
a blood test to measure the level of alpha-galactosidase A activity by micromethod from samples taken from blood spots on filter paper
patients with Fabry disease
detection of this disease in end-stage renal failure patients, transplant or hemodialysis
Intervention: Other: micromethod from samples taken from blood spots on filter paper
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
380
Not Provided
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men aged 18 to 60 years
  • Glomerular filtration rate estimated by MDRD between 60 and 15 ml/min/1, 73m2, or between 90 and 60 ml/min/1,73m2 in association with proteinuria greater than 0.3 g/g creatinine or 0.5 g/l
  • Patient able to understand the benefits and risks of the study
  • Written Consent, informed, signed
  • Patients insured under Social Security,

Exclusion Criteria:

  • Patients with a confirmed diagnosis of Fabry disease
  • Patients belonging to a family in which a diagnosis of Fabry disease was confirmed
  • Patients protected by law (under guardianship).
Male
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01374997
10-PP-04
Not Provided
Département de la recherche clinique et de l'innovation, Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
Not Provided
Principal Investigator: Vincent ESNAULT, PU-PH CHU Nice
Centre Hospitalier Universitaire de Nice
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP