FDA Approval Sought for Two Groundbreaking Kidney Disease Drugs

First Treatments for Patients with Rare Conditions Proven to Work

Suneel Udani, MD

Recently completed medical research could lead to the first ever FDA approved drugs for FSGS and IgA Nephropathy—two conditions with dismal prognoses using current interventions.  Nephrology Associates of Northern Illinois and Indiana (NANI) physicians and researchers nationwide collaborated on groundbreaking studies.

IgA Nephropathy (IgAN) is an autoimmune disease that affects the kidneys and, according to IgA Nephropathy Foundation, it is estimated that 20-40% of the people who have IgAN will develop end-stage kidney disease. This means, that because of IgAN and related conditions, 40% of this group may require dialysis or kidney transplantation to survive. There is no cure for IgAN, but treatments can control the progression of the disease and its symptoms.

Approximately 2 years ago, Travere Therapeutics initiated a study to test the impact of a new therapy to reduce the damage to the kidney caused by IgAN, and slow kidney disease progression. The study is multinational involving investigators around the globe—NANI Research was selected as the Chicagoland site and has been an active partner in the trial. Travere has announced interim results of the trial, demonstrating the group of IgAN patients treated with Sparsentan experienced a 49.8 percent mean reduction of proteinuria after 36 weeks of treatment. Travere expects accelerated FDA approval of Sparsentan for IgAN treatment in first half of 2022.

In addition, since 2019, NANI Research has partnered with Travere in the trial of Sparsentan for treatment of Focal Segmental Glomerulosclerosis (FSGS).  The results of this study have been very promising and may lead to the first-ever FDA approved medication for FSGS. The drug has been shown to limit proteinuria in patients diagnosed with FSGS, just as it may do in IgAN patients, and it is well-tolerated and safe. Limiting proteinuria significantly slows the progression of FSGS, which is a progressive chronic disease that can lead to kidney failure.

Suneel Udani, MD, principal investigator, Nayan Gowda, MD, sub-investigator, and Swarnam Chiramel, Ph.D., study coordinator worked tirelessly with with kidney patients enrolled in the studies by NANI Research. NANI Research is the clinical trials arm of the nation's largest Nephrology specialty practice, NANI.

If you are interested in participating in research, want to know more about NANI Research, or want to refer your patient to a study please reach out to Nancy Cipparrone, Director of Research, ncipparrone@nephdocs.com.

Source: NANI Research

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Categories: Medicine and Healthcare

Tags: Chronic Kidney Disease, clinical trial, FDA Approval, FSGS, IgA Nephropathy, Kidney Disease, Medical research, Nephrology