According to a story from Yahoo Finance, the biopharmaceutical company Mallinckrodt recently released findings from an open label pilot study which tested the impact of Acthar Gel (corticotropin injection) as a treatment for patients with IgA nephropathy, a rare kidney disease. The original study can be found here in the journal Kidney International Reports. The findings from the study suggested that the treatment could reduce proteinuria, or unusual concentrations of protein in the urine.
About IgA Nephropathy
IgA nephropathy, which is also known as Berger’s disease or synpharyngitic glomerulonephritis, is a rare disease which affects the immune system and the kidneys. It is characterized by the inflammation of the glomeruli, a network of capillaries found in the kidneys. In severe cases, the skin and liver may also be affected by the disease. The exact cause of IgA nephropathy is not fully understood, but evidence suggests that the immune system probably plays an important role. Symptoms of the disease include blood in the urine, often triggered by an earlier upper respiratory tract infection. Other symptoms include discolored urine, severe flank pain, swelling in the hands and feet, immune system problems, and elevated blood pressure. Kidney failure is possible in the aggressive variant. There are no approved therapies specifically for IgA nephropathy. Treatment may include steroids, cyclophosphamide, and dietary changes. To learn more about IgA nephropathy, click here.
Proteinuria is associated with an increased risk of progression in patients with chronic kidney disease, which frequently occurs as a result of IgA nephropathy. Around half of patients with IgA nephropathy and proteinuria will progress to end-stage kidney disease in a 15 year period.
About the Study
The study included a total of 19 adult patients that were treated with 80 Acthar Gel units subcutaneously two times per week for a six month period. These patients were followed for a year in total. The primary endpoints were changes in estimated glomerular filtration rate (eGFR), a measure of kidney function, and proteinuria. Eight patients in the study were able to reach partial remission which was defined as a reduction in protein concentration by more than 50 percent. eGFR measures remained stable following treatment with Acthar Gel.
While more study is necessary to determine the true impact of Acthar Gel, the results suggest that at least some patients could stand to benefit. 53 adverse events were reported during the study, including six infections, insomnia, injection reactions, anxiety, hot flashes, acne, and muscle soreness.