Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02526966
• Date of registration: 17/08/2015
• Prospective Registration: No
• Primary sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Public title: Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy NIGA-RA
• Scientific title: Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy
• Date of first enrolment: March 2012
• Target sample size: 68
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02526966
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Christophe MARIAT, MD PhD
• Affiliation: CHU de SAINT-ETIENNE

Key inclusion & exclusion criteria

Inclusion Criteria:

- Major Patient

- Diagnosis of a primitive form of IgA nephropathy histologically proven

Exclusion Criteria:

- Suspicion of secondary IgA nephropathy forms

- Less than 5 glomeruli present on renal biopsy



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

IgA Nephropathy

Intervention(s)

Biological: blood sample

Primary Outcome(s)

serum concentration of anti-hinge region antibodies (mg/ml) [Time Frame: Baseline]

Secondary ID(s)

1108060

2011-A00860-41

Source(s) of Monetary Support

Please refer to primary and secondary sponsors