Immunoglobulin A (IgA) nephropathy is the most prevalent form of glomerulonephritis worldwide. A renal biopsy is required for an accurate diagnosis, as no convenient biomarker is currently available. We developed a serological test based upon the observation that this nephropathy is characterized by undergalactosylated IgA1 in the circulation and in mesangial immune deposits. In the absence of galactose, the terminal saccharide of O-linked chains in the hinge region of IgA1 is terminal or sialylated N-acetylgalactosamine. A lectin from Helix aspersa, recognizing N-acetylgalactosamine, was used to develop an enzyme-linked immunosorbent assay that measures galactose-deficient IgA1 in serum. The median serum lectin-binding IgA1 level was significantly higher for 153 Caucasian adult patients with IgA nephropathy without progression to end-stage renal disease as compared with that for 150 healthy Caucasian adult controls. As the lectin-binding IgA1 levels for the controls were not normally distributed, the 90th percentile was used for determination of significant elevation. Using a value of 1076 U/ml as the upper limit of normal, 117 of the 153 patients with IgA nephropathy had an elevated serum lectin-binding IgA1 level. The sensitivity as a diagnostic test was 76.5%, with specificity 94%; the positive predictive value was 88.6% and the negative predictive value was 78.9%. We conclude that this lectin-binding assay may have potential as a noninvasive diagnostic test for IgA nephropathy.
Arteriovenous graft thrombosis is a frequent event in hemodialysis patients, and usually occurs in grafts with significant underlying stenosis. Regular surveillance for graft stenosis, with pre-emptive angioplasty of significant lesions, may improve graft outcomes. This prospective, randomized, clinical trial allocated 126 hemodialysis patients with grafts to either clinical monitoring alone (control group) or to regular ultrasound surveillance for graft stenosis every 4 months in addition to clinical monitoring (ultrasound group). The two randomized groups were closely matched with respect to demographic, clinical, and graft characteristics, with the exception of a lower frequency of diabetes in the ultrasound group. The primary outcome was graft survival, and the secondary outcome was thrombosis-free graft survival. The frequency of pre-emptive graft angioplasty was 64% higher in the ultrasound group than in the control group (1.05 vs 0.64 events per patient-year, P<0.001), whereas the frequency of thrombosis was not different (0.67 vs 0.78 per patient-year, P=0.37). The median time to permanent graft failure was similar between the two groups (38 vs 37 months, P=0.93). Likewise, the median time to graft thrombosis or failure did not differ (22 vs 25 months, P=0.33). There was no significant association between diabetes and time to graft failure (P=0.93) or time to graft thrombosis or failure (P=0.88). In conclusion, the addition of regular ultrasound surveillance for graft stenosis to clinical monitoring increases the frequency of pre-emptive angioplasty, but may not decrease the likelihood of graft failure or thrombosis.
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