A Step Forward To Treat Incurable Kidney Disease

Sparsentan, a novel treatment for IgA nephropathy, greatly lowers proteinuria, or abnormal protein levels in the urine, when compared to the standard treatment, irbesartan, according to the most recent results from the PROTECT phase III trial.
The interim analysis of PROTECT trial data was given at the World Congress of Nephrology in Bangkok, Thailand, and published in The Lancet on April 1 at the same time.
IgA nephropathy, also referred to as Berger’s disease, is a disorder where kidney inflammation and scarring are brought on by immunoglobulin A (IgA) antibody buildup. IgA is a protein that the body produces in healthy individuals to combat infection, but in patients with IgA nephropathy, it affects kidney function and, over the course of ten years, progresses to end-stage kidney disease in 25% of cases.

Lead author Professor Hiddo Lambers Heerspink, Clinical Pharmacologist at the University Medical Center Groningen, Netherlands, and Director, Better Treatments Program at The George Institute for Global Health said, “IgA nephropathy is a chronic kidney disease with no cure, so optimizing supportive care to slow further kidney damage by reducing proteinuria is vital. This data shows sparsentan was responsible for a rapid and sustained reduction in proteinuria, and this has the potential to prevent progressive kidney function loss in patients with the disease.”

Irbesartan is the active comparator in PROTECT, a multicenter, randomized double-blind, active-controlled study comparing sparsentan to it. At 36 weeks, 280 patients were evaluated as part of a predetermined interim analysis for the main endpoint, which was the change from baseline in the urine protein/creatinine (UP/C) ratio, a metric for proteinuria.

Patients receiving sparsentan experienced a mean decrease in UP/C of 49.8% from baseline, compared to a reduction of 15.1% with irbesartan, for a relative reduction in UP/C of 41%. Like irbesartan, sparsentan demonstrated a positive safety profile. Blood pressure drops and changes in body weight, which serve as proxies for fluid retention, were similar in both treatment groups.

Professor Vlado Perkovic, Dean of Medicine and Health at UNSW, Sydney, and Professorial Fellow at The George Institute for Global Health said, “Sparsentan represents a new class of drug that promises great benefit for patients with IgA nephropathy. With its recent approval in the US and anticipated approval in other countries, I look forward to seeing the difference this treatment could make for those living with IgA nephropathy.”

In order to confirm that sparsentan, when compared to irbesartan, not only lowers proteinuria but also delays the decline of the estimated glomerular filtration rate (eGFR), another indicator of kidney function, the PROTECT trial will continue for an additional 110 weeks.

The George Institute for Global Health is dedicated to tackling the challenges faced by this patient group through improvements to treatment and care because chronic kidney disease affects approximately 10% of the global population.

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