IgA nephropathy (IgAN) – also known as Berger’s disease – is the most common form of glomerulonephritis, a chronic inflammatory condition of the kidney, in the Western world.

IgA nephropathy is a serious autoimmune, progressive disease that leads to decreasing kidney function over the course of 10 to 20 years.

Up to 50 per cent of patients diagnosed with IgAN will progress to end-stage renal disease (ESRD), a disease state requiring dialysis or kidney transplant for survival due to insufficient kidney function within 20 years. IgAN is an orphan disease, designated as an orphan indication in both the US and Europe. IgAN affects approximately 130,000–150,000 people in the US and about 250,000 people in Europe.

Today, there are no approved treatments for IgAN. Today's standard of care treatment regimens entail primarily established, generic drugs such as blood pressure lowering agents to alleviate symptoms, complemented by off-label use of systemic corticosteroids.

End-stage renal disease (ESRD)

ESRD is characterized by an inability of the kidney to remove waste or excess fluid from the blood and is a disease state requiring dialysis or kidney transplant for survival. It is associated with significant risks of complications and quality of life deterioration as well as premature death.

Approximately 700,000 patients per year in the US and an estimated 2 million patients worldwide are affected by ESRD. Glomerulonephritis is a substantial contributor to ESRD cases on an annual basis and IgAN is the largest component of that disease category. At present, ESRD patients have two treatment options:

  1. Transplantation: live and deceased donor kidneys
  2. Dialysis: haemodialysis or peritoneal dialysis