Reducing Proteinuria and Function Loss in IgAN: A Recap of the NefigArd Trial

Announcer:
You’re listening to On the Frontlines of IgAN on ReachMD. On this episode, we’ll discuss the potential immunomodulatory effects of the treatment option Nefecon on patients with immunoglobulin A Nephropathy, or IgAN for short, with Dr. Jonathan Barratt. Not only is he the Mayer Professor of Renal Medicine at the College of Life Sciences University of Leicester, but he’s also a committee member for the International IgA Nephropathy Network. Let’s hear from Dr. Barratt now.

Dr. Barratt:
The NefigArd trial was a phase 3 trial examining the effect of Nefecon in patients with IgA nephropathy at high risk of progression to kidney failure to see how this drug worked in terms of reducing proteinuria and protecting loss of kidney function over a 2-year period. It was a global study recruiting patients from South America, North America, Europe, and Asia, and it has now been reported in the scientific journals. And what the study showed was that treatment with Nefecon resulted in a significant and clinically meaningful reduction in proteinuria at nine months and significantly slowed the rate of loss of kidney function in patients with IgA nephropathy at high risk of future progression to kidney failure.

So Nefecon reduced the risk of loss of kidney function, but importantly, what we found was that it was a safe and well-tolerated treatment. So while there were a small number of side effects related to a small amount of absorption of budesonide into the systemic circulation, these side effects were mild; they reversed on stopping the Nefecon treatment; and in fact, in the study, 95 percent-plus of all patients completed the 9-month treatment with Nefecon. So these side effects were present. They were minor, reversible, and didn’t actually stop the patients from taking the drug. So what we have is a trial that showed that Nefecon is both safe and well tolerated but also that it was able to slow the loss of kidney function in a group of patients with IgA nephropathy at high risk of future kidney failure.

What separates Nefecon from the other available treatments we have for IgA nephropathy is it’s the first drug that has been shown to actually fundamentally alter the immune basis for this disease. So in IgA nephropathy, we believe the fundamental abnormality is the production of immune complexes within the circulation that deposit in the glomeruli causing kidney damage. And these immune complexes are formed because of an excess within the circulation, a particular form of IgA that we believe comes from the mucosal immune system and, in particular, the mucosal immune system of the gut. And what we’ve been able to show through experiments and measurement of these very, very important immune complexes and these changes in the type of IgA in the circulation is that Nefecon suppresses these immune complexes and, therefore, fundamentally alters the disease. This is the only drug that has been shown to do this that is available in clinical care at the moment.

Announcer:
That was Dr. Jonathan Barratt talking about Nefecon and its potential as an IgA nephropathy treatment. To access this and other episodes in our series, visit On the Frontlines of IgAN on ReachMD.com, where you can Be Part of the Knowledge. Thanks for listening!