A recent clinical trial, the largest of its kind examining the effect of oral steroids on patients with immunoglobulin A (IgA) nephropathy, has found a greater than anticipated increase in the risk of serious adverse events.
IgA nephropathy is an immune disease, where the antibody immunoglobulin A causes damage to the kidney. Almost one-third of individuals with IgA experience kidney failure, and require dialysis or transplantation. There is no proven specific therapy for IgA nephropathy, however, current clinical guidelines recommend corticosteroids be considered for patients with IgA nephropathy or persistent proteinuria, as they suppress the immune system, and are relatively affordable.
The ‘TESTING’ study is the largest clinical trial to examine oral steroids as treatment for the disease, with 262 participants – with an average age of 38 years – recruited across Australia and China. In examining the efficacy of oral steroids (methylprednisolone) as a treatment for IgA nephropathy, the trial found the drug to cause increased risk of infection, in addition to bone or gastrointestinal disorders. However, the results of the trial, which have been published in the Journal of the American Medical Association (JAMA), also indicate the oral steroid therapy may have a protective effect on kidney function.
George Clinical Scientific Leader and co-principle investigator of the trial, Professor Vlado Perkovic, the co-principal investigator of the trial and scientific leader of George Clinical, emphasised the importance of using caution in determining which therapy to use for treatment of IgA nephropathy. “While corticosteroids appear likely to have benefits on kidney function, they also have important and potentially life-threatening risks”.
Although a definitive conclusion cannot be made, the TESTING study may pave the way for additional trials on the use of oral steroids in the treatment of IgA nephropathy. “Safer regimens are urgently needed and should be developed and carefully assessed in further trials,” said Professor Perkovic.
George Clinical is a leading independent Asia-Pacific based clinical research organisation (CRO) with global capabilities differentiated by scientific leadership, innovation and extensive investigator networks. With staff operating in 13 countries, George Clinical provides the full range of clinical trial services to biopharmaceutical, medical device and diagnostic customers, for all trial phases, registration and post-marketing trials. George Clinical combines scientific and clinical leadership with expert trial delivery capability to create a distinctive world class service.