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    Food U.S. and Drug Administration. Accelerated approval letter sent to Travere Therapeutics, Inc. February 17, 2023. Accessed November 7, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216403Orig1s000ltr.pdf

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  • 2.

    Heerspink HJL, et al.; PROTECT Investigators. Sparsentan in patients with IgA nephropathy: A prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. Lancet 2023; 401:15841594. doi: 10.1016/S0140-6736(23)00569-X

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    Rovin BH, et al.; DUPRO Steering Committee and PROTECT Investigators. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-Year results from a randomised, active-controlled, phase 3 trial. Lancet (published online November 3, 2023). doi: 10.1016/S0140-6736(23)02302-4

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    Rheault MN, et al.; DUPRO Steering Committee and DUPLEX Investigators. Sparsentan versus irbesartan in focal segmental glomerulosclerosis. N Eng J Med (published online November 3, 2023). doi: 10.1056/NEJMoa2308550

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    Tuttle KR, et al. Study design and baseline characteristics for aldosterone synthase inhibition in CKD. Am J Nephrol (published online October 30, 2023). doi: 10.1159/000534808

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    Heerspink HJ, et al. Zibotentan in combination with dapagliflozin compared with dapagliflozin in patients with chronic kidney disease (ZENITH-CKD): A multicentre, randomised, active-controlled, phase 2b, clinical trial. Lancet (published online November 3, 2023). doi: 10.1016/S0140-6736(23)02230-4

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    Kaufman D, et al. MDR-101-MLK update: Operational immune tolerance achieved in living related HLA-matched kidney transplant recipients [Abstract]. J Am Soc Nephrol 2023; 34:B3

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    Garg AX, et al. Effect of a novel multicomponent intervention to improve patient access to kidney transplant and living kidney donation: The EnAKT LKD cluster randomized clinical trial. JAMA Intern Med (published online November 3, 2023). doi: 10.1001/jamainternmed.2023.5802

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    Akizawa T, et al. AYAME study: Randomized, double-blind, placebo-controlled phase 3 study of bardoxolone methyl in diabetic kidney disease (DKD) patients [Abstract]. J Am Soc Nephrol 2023; 34:B1

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    Nangaku M, et al. Randomized, double-blind, placebo-controlled phase 3 study of bardoxolone methyl in patients with diabetic kidney disease: Design and baseline characteristics of the AYAME study. Nephrol Dial Transplant 2023; 38:12041216. doi: 10.1093/ndt/gfac242

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    Rossingnol P, et al. Aldosterone Antagonist Chronic Hemodialysis Interventional Survival Trial (ALCHEMIST): Primary results [Abstract]. J Am Soc Nephrol 2023; 34:B2

High-Impact Clinical Trials: Sparsentan for IgA Nephropathy and FSGS, SGLT2 Inhibitor Add-On Therapies, Transplant Immunotherapy Alternative Show Promise

Bridget M. Kuehn
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