A clinical trial for the kidney disease drug Medrol has been halted after at least two users died and researchers determined that too many individuals were suffering severe side effects, particularly infections.
According to a report published last week in the Journal of the American Medical Association (JAMA), a multinational group of researchers stopped a study designed to examine the potential benefits of using corticosteroids to treat a form of kidney disease known as IgA Nephropathy, after participants given Medrol were found to be suffering five times the number of harmful side effects as those given a placebo.
IgA nephropathy occurs when an immune system protein known as immunoglobulin A, or IgA, begins to build up in the kidneys. This results in inflammation and leads to other problems. Researchers sought to determine whether Pfizer’s Medrol (methylprednisolone), given orally, could be used as a treatment.
Researchers began a randomized clinical trial with a goal of enrolling 750 patients in five countries, including China, Australia, India, Canada, and Malaysia, with half the patients given Medrol and the other half to be given a placebo. The study was designed to observe patients for a median of five years.
However, the trial was halted after only 262 patients had been enrolled and observed with a median of 2.1 years, due to the high rate of serious adverse health effects among Medrol users.
The partial findings indicated that nearly 15% of patients suffered serious Medrol side effects; compared to only 3.2% of those given a placebo. At least two patients died and most of the adverse events were various types of infections.
Researchers found that, over time, the drug did have a beneficial effect on kidney disease symptoms. However, the infections and health problems came much more rapidly than the drug’s benefits. Since the trial was cancelled early due to the risk to the patients, the full extent or limit of those benefits is unknown.
“Among patients with IgA nephropathy and proteinuria of 1 g/d or greater, oral methylprednisolone was associated with an increased risk of serious adverse events, primarily infections,” the researchers determined. “Although the results were consistent with potential renal benefit, definitive conclusions about treatment benefit cannot be made, owing to early termination of the trial.”