Photo Credit: Mohammed Haneefa Nizamudeen

The following is a summary of “A phase 2b, randomized, double-blind, placebo-controlled, clinical trial of atacicept for treatment of IgA nephropathy,” published in the March 2024 issue of Nephrology by Lafayette et al.

Atacicept is a new, first-in-class, dual anti-B-cell activation factor-A Proliferation-Inducing Ligand fusion protein treatment being tested for IgA nephropathy (IgAN), a kidney condition. It’s a fusion protein that targets specific cells involved in the disease.

Researchers conducted a prospective study comparing how well atacicept works to a placebo in treating IgAN. 

They enrolled 116 patients with biopsy-proven IgAN and randomly assigned to receive atacicept at different doses (25, 75, or 150 mg) or a placebo once a week for up to 36 weeks. The primary goal was to observe changes in urine protein creatinine levels based on 24-hour urine collection at weeks 24 and 36 and compare the atacicept 150 mg and 75 mg group with the placebo group. 

The results showed that at week 24, patients taking atacicept had a 31% decrease in mean urine protein levels compared to 8% with placebo, marking a 25% reduction in atacicept vs. placebo. By week 36, the reduction increased to 34% with atacicept vs. 2% increase with placebo, marking a significant 35% reduction with atacicept vs. placebo. Kidney function remained stable with atacicept compared to decline with placebo at week 6, resulting in a significant between-group geometric mean difference of 11%, approximating an absolute difference of 5.7mL/min/1.73m². Endpoint galactose-deficient IgA1 levels significantly decreased from baseline by 60% vs. placebo. The safety profile of atacicept was similar to that of the placebo.

Investigators concluded that atacicept showed promising results in reducing protein levels in patients with IgAN without significant safety concerns, supporting  moving forward with more extensive phase 3 trials.

Source: kidney-international.org/article/S0085-2538(24)00236-9/fulltext#%20