IgA Nephropathy Patient Baseline Characteristics in the Sparsentan PROTECT Study

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorBARRATT, Jonathan
dc.contributor.authorROVIN, Brad
dc.contributor.authorWONG, Muh Geot
dc.contributor.authorALPERS, Charles E.
dc.contributor.authorBIELER, Stewart
dc.contributor.authorHE, Ping
dc.contributor.authorINRIG, Jula
dc.contributor.authorKOMERS, Radko
dc.contributor.authorHEERSPINK, Hiddo J. L.
dc.contributor.authorMERCER, Alex
dc.contributor.authorNORONHA, Irene L.
dc.contributor.authorRADHAKRISHNAN, Jai
dc.contributor.authorRHEAULT, Michelle N.
dc.contributor.authorROTE, William
dc.contributor.authorTRACHTMAN, Howard
dc.contributor.authorTRIMARCH, Hernan
dc.contributor.authorPERKOVIC, Vlado
dc.contributor.authorPROTECT Investigators
dc.date.accessioned2023-06-21T14:06:24Z
dc.date.available2023-06-21T14:06:24Z
dc.date.issued2023
dc.description.abstractIntroduction: Sparsentan is a novel single-molecule dual endothelin angiotensin receptor antagonist with hemodynamic and anti-inflammatory properties and is not an immunosuppressant. The ongoing phase 3 PROTECT trial examines sparsentan in adults with IgA nephropathy (IgAN). Methods: The PROTECT trial (NCT03762850) is a multicenter, international, randomized, double-blind, parallel-group, active-controlled study. The efficacy and safety of sparsentan versus the active control irbesartan is being evaluated in adults with biopsy-proven IgAN and proteinuria $1.0 g/d despite maxi-mized treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) for at least 12 weeks. Blinded and aggregated baseline characteristics are reported descriptively and compared to contemporary phase 3 trials with patients with IgAN. Results: The primary analysis population includes 404 patients who were randomized and received study drug (median age, 46 years). Enrolled patients were from Europe (53%), Asia Pacific (27%), and North America (20%). Baseline median urinary protein excretion was 1.8 g/d. The range of estimated glomerular filtration rate (eGFR) was broad with the largest proportion of patients (35%) in chronic kidney disease (CKD) stage 3B. Before transitioning to study medication, mean systolic/diastolic blood pressure was 129/ 82 mm Hg, with the majority of patients (63.4%) receiving the maximum labeled ACEi or ARB dose. Pa-tients in Asian versus non-Asian regions included a higher percentage of females, had lower blood pressures, and included lower proportions of patients with a history of hypertension and baseline anti-hypertensive treatment. Conclusions: Patient enrollment in PROTECT, with differing racial backgrounds and across CKD stages, will allow for important characterization of the treatment effect of sparsentan in patients with IgAN with proteinuria at high risk of kidney failure.eng
dc.description.indexPubMed
dc.description.indexWoS
dc.description.indexScopus
dc.description.sponsorshipTravere Therapeutics, Inc.
dc.identifier.citationKIDNEY INTERNATIONAL REPORTS, v.8, n.5, p.1043-1056, 2023
dc.identifier.doi10.1016/j.ekir.2023.02.1086
dc.identifier.issn2468-0249
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/53820
dc.language.isoeng
dc.publisherELSEVIER SCIENCE INCeng
dc.relation.ispartofKidney International Reports
dc.rightsopenAccesseng
dc.rights.holderCopyright ELSEVIER SCIENCE INCeng
dc.subjectdual endothelin angiotensin receptor antagonisteng
dc.subjectethnicityeng
dc.subjectimmunoglobulin A nephropathyeng
dc.subjectraceeng
dc.subjectran-domized controlled clinical trialeng
dc.subjectsparsentaneng
dc.subject.otherendothelineng
dc.subject.otherantagonistseng
dc.subject.otherrationaleeng
dc.subject.otherat(1)eng
dc.subject.wosUrology & Nephrologyeng
dc.titleIgA Nephropathy Patient Baseline Characteristics in the Sparsentan PROTECT Studyeng
dc.typearticleeng
dc.type.categoryoriginal articleeng
dc.type.versionpublishedVersioneng
dspace.entity.typePublication
hcfmusp.affiliation.countryAustrália
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryInglaterra
hcfmusp.affiliation.countryArgentina
hcfmusp.affiliation.countrySuécia
hcfmusp.affiliation.countryisogb
hcfmusp.affiliation.countryisous
hcfmusp.affiliation.countryisoau
hcfmusp.affiliation.countryisose
hcfmusp.affiliation.countryisoar
hcfmusp.author.externalBARRATT, Jonathan:Univ Leicester Gen Hosp, Dept Cardiovasc Sci, Leicester, England
hcfmusp.author.externalROVIN, Brad:Ohio State Univ, Div Nephrol, Wexner Med Ctr, Columbus, OH 43210 USA
hcfmusp.author.externalWONG, Muh Geot:Concord Repatriat Gen Hosp, Dept Renal Med, Concord, NSW, Australia; Univ Sydney, Concord Clin Sch, Concord, NSW, Australia
hcfmusp.author.externalALPERS, Charles E.:Univ Washington, Dept Lab Med & Pathol, Seattle, WA USA
hcfmusp.author.externalBIELER, Stewart:Travere Therapeut Inc, San Diego, CA USA
hcfmusp.author.externalHE, Ping:Travere Therapeut Inc, San Diego, CA USA
hcfmusp.author.externalINRIG, Jula:Travere Therapeut Inc, San Diego, CA USA
hcfmusp.author.externalKOMERS, Radko:Travere Therapeut Inc, San Diego, CA USA
hcfmusp.author.externalHEERSPINK, Hiddo J. L.:Univ Groningen, Univ Med Ctr Groningen, Dept Clin Pharm & Pharmacol, Groningen, Netherlands; Univ New South Wales, George Inst Global Hlth, Sydney, NSW, Australia
hcfmusp.author.externalMERCER, Alex:JAMCO Pharm Consulting, Stockholm, Sweden
hcfmusp.author.externalRADHAKRISHNAN, Jai:Columbia Univ, Div Nephrol, New York, NY USA
hcfmusp.author.externalRHEAULT, Michelle N.:Univ Minnesota, Div Pediat Nephrol, Med Sch, Minneapolis, MN USA
hcfmusp.author.externalROTE, William:Travere Therapeut Inc, San Diego, CA USA
hcfmusp.author.externalTRACHTMAN, Howard:Univ Michigan, Dept Pediat, Div Nephrol, Ann Arbor, MI USA
hcfmusp.author.externalTRIMARCH, Hernan:Univ New South Wales, George Inst Global Hlth, Sydney, NSW, Australia; Hosp Britan Buenos Aires, Nephrol Serv, Buenos Aires, Argentina
hcfmusp.author.externalPERKOVIC, Vlado:Univ New South Wales, George Inst Global Hlth, Sydney, NSW, Australia; Univ New South Wales, Fac Med & Hlth, Sydney, NSW, Australia
hcfmusp.citation.scopus12
hcfmusp.contributor.author-fmusphcIRENE DE LOURDES NORONHA
hcfmusp.description.beginpage1043
hcfmusp.description.endpage1056
hcfmusp.description.issue5
hcfmusp.description.volume8
hcfmusp.origemWOS
hcfmusp.origem.pubmed37180506
hcfmusp.origem.scopus2-s2.0-85151249506
hcfmusp.origem.wosWOS:000991105300001
hcfmusp.publisher.cityNEW YORKeng
hcfmusp.publisher.countryUSAeng
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