{"id":5030,"date":"2023-04-01T14:23:00","date_gmt":"2023-04-01T14:23:00","guid":{"rendered":"https:\/\/medicalaffairs.travere.com\/?post_type=publication&#038;p=5030"},"modified":"2025-09-30T23:58:19","modified_gmt":"2025-09-30T23:58:19","slug":"sparsentan-iga-nephropathy-protect-interim-analysis","status":"publish","type":"publication","link":"https:\/\/clleancode.top\/travere-redesign\/publications\/sparsentan-iga-nephropathy-protect-interim-analysis\/","title":{"rendered":"Sparsentan in Patients With IgA Nephropathy: A Prespecified Interim Analysis From a Randomised, Double-Blind, Active-Controlled Clinical Trial"},"content":{"rendered":"\n\n\n\n<section class=\"o-hero-section o-hero--banner o-hero--blue o-hero--cropped\">\n    <img decoding=\"async\" width=\"1920\" height=\"1080\" src=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/08\/sparsentan-clinical-trial_header.png\" class=\"a-img a-img--right h-full\" alt=\"Hero Section Background Image\" 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class=\"breadcrumbs\" aria-label=\"breadcrumb\"><span><span><a href=\"https:\/\/clleancode.top\/travere-redesign\/\">Home<\/a><\/span><\/span><\/nav>            <\/div>\n            <h1 class=\"a-heading a-heading--h1 h-white\">Sparsentan in Patients With IgA Nephropathy: A Prespecified Interim Analysis From a Randomised, Double-Blind, Active-Controlled Clinical Trial<\/h1>                    <\/div>\n    <\/div>\n<\/section>\n\n\r\n\t<section style=\"margin-top:calc(-150px * var(--scale));\" class=\"section-container wp-block-grizzly-section-container\">\r\n\t\t\t\t<div class=\"container\">\r\n\t\t\t\n\n<div class=\"wp-block-group is-layout-constrained wp-container-core-group-is-layout-09ab29e6 wp-block-group-is-layout-constrained\">\n<div class=\"info-block info-block-publication search__container-publication search__container\">\n\t<div class=\"info-block-top\">\n\t\t<div>\n\t\t\t\t\t\t\t<div class=\"info-block-type\"><i class=\"icon2-journal\"><\/i> Journal article<\/div>\n\t\t\t\n\t\t\t\t\t\t\t<div class=\"info-block-type\">\n\t\t\t\t\t<i class=\"icon2-calendar\"><\/i> Published on April 1, 2023\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div class=\"m-tags\">\n\t\t\t\t<p>Topics: <\/p>\n\t\t\t\t\t\t\t\t\t<span class=\"a-tag\">Nephrology<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"a-tag\">IgAN<\/span>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t<\/div>\n\n\t<div class=\"info-block-bottom\">\n\t\t\t\t\t<div class=\"info-block-box\">\n\t\t\t\tContributors:<br \/><span>Heerspink HJL, Radhakrishnan J, Alpers CE et al.<\/span>\n\t\t\t<\/div>\n\t\t\n\t\t<div class=\"info-block-box\">\n\t\t\t\t\t\t\tName of Journal:<br \/><span>The Lancet<\/span><br \/><br \/><br \/>\n\t\t\t\n\t\t\t\t\t\t\t<a href=\"#\" data-url=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(23)00569-X\/abstract\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"btn btn-outline leaving-modal-toggle btn-leaving\" aria-label=\"View Publication\">View Publication<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div class=\"info-block-box info-block-doi\">\n\t\t\t\tDOI:<br \/><span>10.1016\/S0140-6736(23)00569-X<\/span>\n\t\t\t<\/div>\n\t\t\n\t\t<div class=\"info-block-share\">Share:\n\t\t\t<span>\n\t\t\t\t\t<a href=\"https:\/\/twitter.com\/intent\/tweet?url=https%3A%2F%2Fclleancode.top%2Ftravere-redesign%2Fpublications%2Fsparsentan-iga-nephropathy-protect-interim-analysis%2F&#038;text=Sparsentan+in+Patients+With+IgA+Nephropathy%3A+A+Prespecified+Interim+Analysis+From+a+Randomised%2C+Double-Blind%2C+Active-Controlled+Clinical+Trial\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"icon2-x\" aria-label=\"Share on Twitter\"><\/a> \n\t<a 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For more information, review the <a href=\"https:\/\/travere.com\/privacy\/\" target=\"_blank\">Travere privacy policies<\/a>.<\/span><\/label><\/span><\/span><\/span>\n  <\/div>\n  <div class=\"form-group text-right\">\n    <input class=\"wpcf7-form-control wpcf7-submit has-spinner btn\" id=\"request-submit\" type=\"submit\" value=\"Yes, continue\" \/>\n  <\/div>\n<\/div><div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div>\n<\/form>\n<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div> <\/div>\n\n\t\t<\/div>\r\n\t<\/section>\r\n\t\n\n\r\n\t<section class=\"section-container wp-block-grizzly-section-container\">\r\n\t\t\t\t<div class=\"container\">\r\n\t\t\t\n\n<div class=\"wp-block-group is-layout-constrained wp-container-core-group-is-layout-09ab29e6 wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-text-align-center has-heading-4-font-size\" id=\"h-summary\" style=\"margin-top:calc(60px * var(--scale));margin-bottom:calc(30px * var(--scale))\"><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-teal-color\">Summary<\/mark><\/span><br><\/h2>\n\n\n\n<h3 class=\"wp-block-heading has-heading-5-font-size\" id=\"h-the-protect-interim-analysis-demonstrated-reduction-in-proteinuria-and-a-comparable-safety-profile-with-sparsentan-in-iga-nephropathy-versus-irbesartan-1\"><span class=\"fw-600\">The PROTECT interim analysis demonstrated reduction in proteinuria and a comparable safety profile with sparsentan in IgA nephropathy versus irbesartan<sup>1<\/sup><\/span><\/h3>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-heading-5-font-size\" id=\"h-background\"><br><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\">Background<\/mark><\/span><\/h4>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>IgA nephropathy is an important cause of kidney failure and is the most prevalent primary chronic glomerular disease worldwide.<sup>2<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Proteinuria is a risk factor for loss of kidney function in patients with IgA nephropathy.<sup>2<\/sup> Treatment of proteinuria &gt;0.5 g\/day with renin-angiotensin system inhibitors (RASi) is recommended in treatment guidelines.<sup>3<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Studies suggest that in addition to activation of the renin-angiotensin system (RAS), <span style=\"text-decoration: underline;\"><a href=\"https:\/\/clleancode.top\/travere-redesign\/episode\/role-of-endothelin-in-igan\/\">endothelin-1<\/a><\/span> (ET-1) signaling is a potential therapeutic target for renal diseases.<sup>4<\/sup> Combined use of RASis and endothelin type A receptor (ET<sub>A<\/sub>R) antagonists have shown additional beneficial effects in experimental models of kidney disease and in those with diabetic and non-diabetic nephropathies.<sup>5-8<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Sparsentan is a non-immunosuppressive, single-molecule, <span style=\"text-decoration: underline;\"><a href=\"https:\/\/clleancode.top\/travere-redesign\/publications\/protective-mechanism-sparsentan-chronic-kidney-disease-models\/\">dual endothelin and angiotensin receptor antagonist<\/a><\/span> that can be used to reduce proteinuria in adults with IgA nephropathy.<sup>9<\/sup><\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\" id=\"h-aim\"><br><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\">Aim<\/mark><\/span><\/h5>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The Phase 3 PROTECT study evaluated the long-term efficacy and safety of sparsentan in IgA nephropathy versus irbesartan.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\" id=\"h-approach\"><br><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\">Approach<\/mark><\/span><\/h5>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>PROTECT is a large, international, randomized, double-blind, active-controlled Phase 3 trial of sparsentan versus irbesartan in adults with IgA nephropathy.<sup>1<\/sup> Eligibility criteria included<sup>1<\/sup>:<\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-list-wrapper\">\n<ul class=\"wp-block-list\">\n<li>Biopsy-proven IgA nephropathy<\/li>\n\n\n\n<li>Proteinuria \u22651.0&nbsp;g\/day<\/li>\n\n\n\n<li>Maximum tolerated (stable) dose of RASi therapy for \u226512 weeks<\/li>\n<\/ul>\n<\/div>\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Participants were randomized to sparsentan 400 mg once daily (QD) (n=202) or irbesartan 300 mg QD (n=202).<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The primary efficacy endpoint was change from baseline to Week 36 in urine protein-creatinine ratio (UPCR).<sup>1 <\/sup>Safety endpoints included treatment-emergent adverse events (TEAE) and liver enzyme elevations.<sup>1<\/sup> The data herein are from a prespecified interim analysis and derived from the on-treatment full analysis set, which included all participants who received at least one dose of randomized treatment.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Read more about the <span style=\"text-decoration: underline;\"><a href=\"https:\/\/clleancode.top\/travere-redesign\/publications\/efficacy-and-safety-of-sparsentan-versus-irbesartan-in-patients-with-iga-nephropathy-protect-2-year-results-from-a-randomised-active-controlled-phase-3-trial-2\/\">two-year efficacy and safety findings<\/a><\/span> from the PROTECT trial or <span style=\"text-decoration: underline;\"><a href=\"https:\/\/clleancode.top\/travere-redesign\/protect-podcast\/\">listen now<\/a><\/span>.<\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\" id=\"h-findings\"><br><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\"><span class=\"fw-600\">Findings<\/span><\/mark><\/h5>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><span class=\"fw-600\">Baseline demographic and characteristics were well balanced between treatment groups<sup>1<\/sup><\/span><\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-list-wrapper\">\n<ul class=\"wp-block-list\">\n<li><span class=\"fw-600\">Age (mean):<\/span> 46.0 years<\/li>\n\n\n\n<li><span class=\"fw-600\">Estimated glomerular filtration rate (eGFR) (mean):<\/span> 57.0 mL\/min per 1.73 m\u00b2<\/li>\n\n\n\n<li><span class=\"fw-600\">Urine protein excretion (mean):<\/span> 1.8 g\/day<\/li>\n\n\n\n<li><span class=\"fw-600\">Angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at maximum labeled dose at screening:<\/span> 63.5%<\/li>\n<\/ul>\n<\/div>\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><span class=\"fw-600\">The primary endpoint, reduction in UPCR from baseline, was greater with sparsentan versus irbesartan<sup>1<\/sup><\/span><\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>At Week 36, the mean change in UPCR was significantly greater in the sparsentan group than in the irbesartan group (-49.8% versus -15.1%, respectively).<sup>1<\/sup> The between group relative reduction was 41% (geometric least squares mean ratio [sparsentan\/irbesartan] = 0.59, 95% CI: 0.51-0.69; <em>P<\/em>&lt;0.0001).<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>This reduction was evident at Week 4 of the study and was maintained throughout follow-up.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><span class=\"fw-600\">The beneficial effect of sparsentan versus irbesartan on UPCR was consistent across subgroups<sup>1<\/sup><\/span><\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Subgroup analysis showed a consistent benefit from sparsentan versus irbesartan among demographic subgroups, and notably, in subgroups stratified by baseline eGFR and urine protein excretion.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><span class=\"fw-600\">Safety was similar between sparsentan and irbesartan<sup>1<\/sup><\/span><\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>TEAEs were mostly similar across treatment groups.<sup>1<\/sup> TEAEs that occurred in a greater proportion (\u22654% difference) of patients receiving sparsentan versus irbesartan were, respectively<sup>1<\/sup>:<\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-list-wrapper\">\n<ul class=\"wp-block-list\">\n<li><span class=\"fw-600\">Peripheral edema:<\/span> 14% versus 9%<\/li>\n\n\n\n<li><span class=\"fw-600\">Hypotension:<\/span> 14% versus 6%<\/li>\n\n\n\n<li><span class=\"fw-600\">Dizziness:<\/span> 13% versus 5%<\/li>\n<\/ul>\n<\/div>\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>There were no cases of heart failure, hepatotoxicity, or severe edema or edema-related discontinuations.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\" id=\"h-key-takeaway\"><br><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\">Key takeaway<\/mark><\/span><\/h5>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The interim analysis of the PROTECT study demonstrated a meaningful antiproteinuric effect of sparsentan in IgA nephropathy versus irbesartan and a comparable safety profile.<sup>1<\/sup><br><br><br><br><br><\/p>\n\n\n\n<div class=\"newsletter\">\n\t<div class=\"newsletter-icon\">\n\t\t<span class=\"icon2-newsletter\"><\/span>\n\t<\/div>\n\t<div class=\"newsletter-text\">\n\t\t<p><strong>Sign up<\/strong> to receive scientific updates<br \/>\nfor healthcare professionals<br \/>\nfrom Travere Therapeutics.<\/p>\n\t<\/div>\n\t<div class=\"newsletter-form\">\n\t\t<script type=\"text\/javascript\">\n\/* <![CDATA[ *\/\nvar gform;gform||(document.addEventListener(\"gform_main_scripts_loaded\",function(){gform.scriptsLoaded=!0}),document.addEventListener(\"gform\/theme\/scripts_loaded\",function(){gform.themeScriptsLoaded=!0}),window.addEventListener(\"DOMContentLoaded\",function(){gform.domLoaded=!0}),gform={domLoaded:!1,scriptsLoaded:!1,themeScriptsLoaded:!1,isFormEditor:()=>\"function\"==typeof 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\t\t\t\t\t2023\t\t\t\t<\/p>\n\t\t\t<\/div>\n\t\t\t\t\t\t\t<a href=\"https:\/\/clleancode.top\/travere-redesign\/publications\/protect-2-year-results-sparsentan-vs-irbesartan-iga-nephropathy\/\" class=\"a-btn a-btn--secondary--blue\"  aria-label=\"Read more: Efficacy and Safety of Sparsentan Versus Irbesartan in Patients with IgA Nephropathy (PROTECT): 2-Year Results From a Randomised Active-Controlled Phase 3 Trial\">\n\t\t\t\t\t<span>Read more<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t<\/article>\n\t<article class=\"m-card  \" aria-label=\"Publication card: IgA Nephropathy Patient Baseline Characteristics in the Sparsentan PROTECT Study\">\n\t\t<div class=\"m-card__top\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/clleancode.top\/travere-redesign\/?post_type=publication&#038;p=4611\"  aria-label=\"View publication: IgA Nephropathy Patient Baseline Characteristics in the Sparsentan PROTECT Study\">\n\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1920\" height=\"767\" src=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/Group-of-people-header.png\" class=\"a-img\" alt=\"IgA Nephropathy Patient Baseline Characteristics in the Sparsentan PROTECT Study\" loading=\"lazy\" srcset=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/Group-of-people-header.png 1920w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/Group-of-people-header-300x120.webp 300w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/Group-of-people-header-1024x409.webp 1024w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/Group-of-people-header-768x307.webp 768w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/Group-of-people-header-1536x614.webp 1536w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/Group-of-people-header-290x116.webp 290w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/>\t\t\t\t\t\t\t<\/a>\n\t\t\t<div class=\"m-card__info\">\n\t\t\t\t<div class=\"m-tags\">\n\t\t\t\t\t<span class=\"a-tag h-blue\">\n\t\t\t\t\t\t<i class=\"icon4 icon4-publication\"><\/i> Publication\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<span class=\"a-tag h-blue\">Nephrology<\/span><span class=\"a-tag h-blue\">IgAN<\/span>\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<div class=\"m-card__bottom m-card--padding\">\n\t\t\t<div class=\"m-card__text\">\n\t\t\t\t<p class=\"a-heading a-heading--h4 h-ultra-dark-blue h-text-ellipsis h-w-medium\">\n\t\t\t\t\tIgA Nephropathy Patient Baseline Characteristics in the Sparsentan PROTECT Study\t\t\t\t<\/p>\n\t\t\t\t<p class=\"a-text a-text--m h-ultra-dark-blue\">\n\t\t\t\t\t<em>Kidney International Reports<\/em> \n\t\t\t\t\t &#8211; \t\t\t\t\t2023\t\t\t\t<\/p>\n\t\t\t<\/div>\n\t\t\t\t\t\t\t<a href=\"https:\/\/clleancode.top\/travere-redesign\/?post_type=publication&#038;p=4611\" class=\"a-btn a-btn--secondary--blue\"  aria-label=\"Read more: IgA Nephropathy Patient Baseline Characteristics in the Sparsentan PROTECT Study\">\n\t\t\t\t\t<span>Read more<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t<\/article>\n\t<article class=\"m-card  \" aria-label=\"Publication card: Implementing the Kidney Health Initiative Surrogate Efficacy Endpoint in Patients With IgA Nephropathy (the PROTECT Trial)\">\n\t\t<div class=\"m-card__top\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/clleancode.top\/travere-redesign\/?post_type=publication&#038;p=2390\"  aria-label=\"View publication: Implementing the Kidney Health Initiative Surrogate Efficacy Endpoint in Patients With IgA Nephropathy (the PROTECT Trial)\">\n\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1920\" height=\"1080\" src=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2019\/10\/PROTECT-surrogate-efficacy-endpoints_header.png\" class=\"a-img\" alt=\"Implementing the Kidney Health Initiative Surrogate Efficacy Endpoint in Patients With IgA Nephropathy (the PROTECT Trial)\" loading=\"lazy\" srcset=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2019\/10\/PROTECT-surrogate-efficacy-endpoints_header.png 1920w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2019\/10\/PROTECT-surrogate-efficacy-endpoints_header-300x169.webp 300w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2019\/10\/PROTECT-surrogate-efficacy-endpoints_header-1024x576.webp 1024w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2019\/10\/PROTECT-surrogate-efficacy-endpoints_header-768x432.webp 768w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2019\/10\/PROTECT-surrogate-efficacy-endpoints_header-1536x864.webp 1536w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2019\/10\/PROTECT-surrogate-efficacy-endpoints_header-290x163.webp 290w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/>\t\t\t\t\t\t\t<\/a>\n\t\t\t<div class=\"m-card__info\">\n\t\t\t\t<div class=\"m-tags\">\n\t\t\t\t\t<span class=\"a-tag h-blue\">\n\t\t\t\t\t\t<i class=\"icon4 icon4-publication\"><\/i> Publication\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<span class=\"a-tag h-blue\">Nephrology<\/span><span class=\"a-tag h-blue\">IgAN<\/span>\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<div class=\"m-card__bottom m-card--padding\">\n\t\t\t<div class=\"m-card__text\">\n\t\t\t\t<p class=\"a-heading a-heading--h4 h-ultra-dark-blue h-text-ellipsis h-w-medium\">\n\t\t\t\t\tImplementing the Kidney Health Initiative Surrogate Efficacy Endpoint in Patients With IgA Nephropathy (the PROTECT Trial)\t\t\t\t<\/p>\n\t\t\t\t<p class=\"a-text a-text--m h-ultra-dark-blue\">\n\t\t\t\t\t<em>Kidney International Reports<\/em> \n\t\t\t\t\t &#8211; \t\t\t\t\t2019\t\t\t\t<\/p>\n\t\t\t<\/div>\n\t\t\t\t\t\t\t<a href=\"https:\/\/clleancode.top\/travere-redesign\/?post_type=publication&#038;p=2390\" class=\"a-btn a-btn--secondary--blue\"  aria-label=\"Read more: Implementing the Kidney Health Initiative Surrogate Efficacy Endpoint in Patients With IgA Nephropathy (the PROTECT Trial)\">\n\t\t\t\t\t<span>Read more<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t<\/article>\n\t\t<\/div>\n\t\t<div class=\"publication-related-btn\">\n\t\t\t<a href=\"https:\/\/clleancode.top\/travere-redesign\/publications\/\" class=\"a-btn a-btn--primary\" aria-label=\"See more\">See more<\/a>\n\t\t<\/div>\n\t<\/div>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\" id=\"h-footnotes\" style=\"margin-bottom:calc(30px * var(--scale))\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\"><span class=\"fw-600\">Footnotes<\/span><\/mark><\/h5>\n\n\n\n<p class=\"has-small-font-size\" style=\"margin-bottom:calc(30px * var(--scale))\">ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; eGFR, estimated glomerular filtration rate; ET-1, endothelin-1; ET<sub>A<\/sub>R, endothelin type A receptor; QD, once daily; RAS, renin-angiotensin system; RASi, renin-angiotensin system inhibitor; TEAE, treatment-emergent adverse event; UPCR, urine protein-creatinine ratio.<\/p>\n\n\n<div class=\"wp-block-list-wrapper\">\n<ol class=\"wp-block-list has-small-font-size\">\n<li class=\"has-small-font-size\">Heerspink HJL et al. <em>Lancet.<\/em> 2023;401(10388):1584-1594.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Wyatt RJ, Julian BA. <em>N Engl J Med<\/em>. 2013;368:2402-2414.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. <em>Kidney Int.<\/em> 2021;100(4S):S1-S276.<\/li>\n\n\n\n<li class=\"has-small-font-size\">De Miguel C et al. <em>Curr Opin Nephrol Hypertens.<\/em> 2016;25(1):35-41.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Komers R, Plotkin H. <em>Am J Physiol Regul Integr Comp Physiol.<\/em> 2016;310(10):R877-R884.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Trachtman H et al. <em>Drugs Future.<\/em> 2020;45(2):79.<\/li>\n\n\n\n<li class=\"has-small-font-size\">de Zeeuw D et al. <em>J Am Soc Nephrol.<\/em> 2014;25(5):1083-1093.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Dhaun N et al. <em>Hypertension. <\/em>2011;157(4):772-774.<\/li>\n\n\n\n<li class=\"has-small-font-size\">FILSPARI<sup>\u00ae<\/sup> (sparsentan) Prescribing Information. San Diego, CA: Travere Therapeutics, Inc. 9\/2024.<\/li>\n<\/ol>\n<\/div>\n\n\n<p class=\"has-text-align-right\" style=\"margin-top:calc(30px * var(--scale));margin-bottom:calc(300px * var(--scale))\">MA-SP-24-0102 | October 2024<\/p>\n<\/div>\n\n\t\t<\/div>\r\n\t<\/section>\r\n\t","protected":false},"featured_media":4773,"template":"","meta":{"inline_featured_image":false,"header_bg_color":"transparent","header_fixed":true,"post_description":"","post_download_link":"","journal_link":"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(23)00569-X\/fulltext","pdf_file_link":"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/Heerspink-LANCET-2023-PROTECT-Interim.pdf"},"product":[78],"therapeutic_area":[97],"disease_area":[174],"study_registry":[175],"study_type":[176],"resource_type":[177,180],"class_list":["post-5030","publication","type-publication","status-publish","has-post-thumbnail","hentry","product-spa","therapeutic_area-neph","disease_area-igan","study_registry-protect","study_type-clinical","resource_type-publication","resource_type-summary"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.9 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>PROTECT Interim Analysis: Efficacy and Safety of Sparsentan in IgAN | Travere Medical Affairs<\/title>\n<meta name=\"description\" content=\"Learn more about the efficacy and safety findings from the PROTECT interim analysis of sparsentan in adults with IgA nephropathy versus irbesartan. 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