FDA Approval Sought for Two Groundbreaking Kidney Disease Drugs
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 we have 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. Read the announcement here
In addition, since 2019, NANI Research has partnered with Travere in the trial of Sparsentan for treatment of Focal Segmental Glomerulosclerosis (FSGS). The results to date have also 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. Read the full press release here
NANI Research is proud to have had a role in these trials, which could lead to the first ever FDA approved drugs for FSGS and IgA Nephropathy—two conditions with dismal prognoses using current interventions.
NANI Research thanks Suneel Udani, MD, principal investigator, Nayan Gowda, MD, sub-investigator, and Swarnam Chiramel, PhD, study coordinator ~ for without their dedication to research we would not have been able to perform these trials.
This is why we do research, and this is why YOU should be part of research by serving as an investigator or referring your patients to ongoing trials.
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, or visit clinical trials page.
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