IgA Nephropathy Patient Baseline Characteristics in the Sparsentan PROTECT Study

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art_BARRATT_IgA_Nephropathy_Patient_Baseline_Characteristics_in_the_Sparsentan_2023.PDF (316.46 KB)
Citações na Scopus
11
Tipo de produção
article
Data de publicação
2023
DOI
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
ELSEVIER SCIENCE INC
Autores
BARRATT, Jonathan
ROVIN, Brad
WONG, Muh Geot
ALPERS, Charles E.
BIELER, Stewart
HE, Ping
INRIG, Jula
KOMERS, Radko
HEERSPINK, Hiddo J. L.
MERCER, Alex
Citação
KIDNEY INTERNATIONAL REPORTS, v.8, n.5, p.1043-1056, 2023
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
Introduction: 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.
Palavras-chave
dual endothelin angiotensin receptor antagonist, ethnicity, immunoglobulin A nephropathy, race, ran-domized controlled clinical trial, sparsentan
URI
https://observatorio.fm.usp.br/handle/OPI/53820
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Coleções
Artigos e Materiais de Revistas Científicas - FM/MCM
Artigos e Materiais de Revistas Científicas - HC/ICHC
Artigos e Materiais de Revistas Científicas - LIM/29
Artigos e Materiais de Revistas Científicas - ODS/03