The report, published in JAMA recently, finds that treatment with methylprednisolone was associated, surprisingly, with an increased risk of serious adverse events, primarily infections in patients with IgA nephropathy and excess protein in their urine.
Nearly one-third of patients with IgA nephropathy, which occurs when the antibody IgA lodges in the kidneys, eventually develop end-stage kidney disease. The strongest risk factors are decreased kidney function, persistent proteinuria, and hypertension, according to the study team led by researchers from Peking University First Hospital in Beijing and the George Institute for Global Health, University of New South Wales in Sydney, Australia.
To explore the risks and benefits of treatment, the researchers randomly assigned about 260 study participants with IgA nephropathy and proteinuria to either oral methylprednisolone or placebo for 2 months and then weaned them over 4 to 6 months.
Recruitment was discontinued, however, after 2.1 years’ median follow-up because of an unanticipated elevated rate of serious adverse events, including infections, gastrointestinal issues, and bone disorders.
The report notes that serious events occurred in 14.7% of participants in the methylprednisolone group versus 3.2% in the placebo group. Most of the issues were related to serious infections and resulted in two deaths, study authors write.
At the same time, end-stage kidney disease, death due to kidney failure, or a 40% decrease in estimated glomerular filtration rate—the primary renal outcomes—occurred in 5.9% of the methylprednisolone group compared with15.8% of the placebo group.
“Although the results were consistent with potential renal benefit, definitive conclusions about treatment benefit cannot be made, owing to early termination of the trial,” the authors point out. They note that having to stop recruitment early decreased the power of the study to appropriately estimate risks and benefits.
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