A Randomized Controlled Trial of Intravenous Immunoglobulin vs Standard of Care for the Treatment of Chronic Active Antibody-Mediated Rejection in Kidney Transplant Recipients (VIPAR)
In the small randomized VIPAR trial, six monthly high-dose intravenous immunoglobulin (IVIG) infusions stabilized allograft histology and kidney function in transplant recipients with chronic active antibody-mediated rejection, whereas untreated patients showed progressive damage and faster eGFR decline.
Background
Chronic active antibody-mediated rejection is the leading cause of death-censored kidney allograft loss, with no proven treatment. IVIG has been used empirically, but its efficacy had never been tested in a randomized trial.
Study design
VIPAR was an open-label, multicenter randomized controlled trial. Thirty recipients with biopsy-proven chronic active AMR (15 per arm) were assigned to six monthly doses of IVIG (1 g/kg) or no IVIG. The primary endpoint was the difference between groups in the slope of the chronic allograft damage index (CADI) across four biopsies over 12 months; secondary outcomes included eGFR change, donor-specific antibodies, survival, and intra-graft gene expression.
Key findings
The no-IVIG group had a significant rise in CADI (+0.28/month, 95% CI 0.14 to 0.41), whereas the IVIG group did not (−0.004/month). Over 2 years, eGFR declined faster without IVIG (−1.1 vs −0.4 ml/min/month). Patient and allograft survival did not differ by 12 months. IVIG reduced intra-graft expression of 59 mostly B-cell-related genes.
Clinical implications
Prolonged high-dose IVIG was associated with stabilization of histology and kidney function in chronic active AMR, offering preliminary support for a treatment in a setting with no approved options. Given the very small sample size and open-label design, the findings are encouraging but require confirmation in larger trials.
Category
Transplant
Source
Kidney International
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