Implications of Complete Proteinuria Remission at any Time in Focal Segmental Glomerulosclerosis: Sparsentan DUET Trial.

complete remission estimated glomerular filtration rate focal segmental glomerulosclerosis open-label extension proteinuria surrogate endpoint

Journal

Kidney international reports
ISSN: 2468-0249
Titre abrégé: Kidney Int Rep
Pays: United States
ID NLM: 101684752

Informations de publication

Date de publication:
Oct 2023
Historique:
received: 03 02 2023
revised: 12 06 2023
accepted: 24 07 2023
medline: 18 10 2023
pubmed: 18 10 2023
entrez: 18 10 2023
Statut: epublish

Résumé

Focal segmental glomerulosclerosis (FSGS) is a rare glomerular disease with high unmet clinical need. Interest in proteinuria as a surrogate end point for regulatory approval of novel treatments has increased. We assessed the relationship between achieving complete remission (CR) of proteinuria at least once during follow-up and long-term kidney outcomes. This A total of 108 patients who received ≥1 sparsentan dose were included in this study. During a median follow-up of 47.0 months, 46 patients (43%) experienced ≥1 CR, 61% occurring within 12 months of starting sparsentan. There was an increased likelihood of CR with a higher sparsentan dose or baseline subnephrotic-range proteinuria. Achieving ≥1 CR was associated with significantly slower rate of estimated glomerular filtration rate (eGFR) decline versus non-CR patients ( We conclude that sparsentan can be safely administered for extended periods and exerts a sustained antiproteinuric effect. Achievement of CR at any time during follow-up, even if it is not sustained, may be an indicator of a favorable response to treatment and a predictor of improved kidney function outcomes.

Identifiants

pubmed: 37850006
doi: 10.1016/j.ekir.2023.07.022
pii: S2468-0249(23)01401-8
pmc: PMC10577371
doi:

Types de publication

Journal Article

Langues

eng

Pagination

2017-2028

Informations de copyright

© 2023 International Society of Nephrology. Published by Elsevier Inc.

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Auteurs

Howard Trachtman (H)

Division of Nephrology, Department of Pediatrics, University of Michigan, Ann Arbor, Michigan, USA.

Ulysses Diva (U)

Biometrics, Travere Therapeutics, Inc., San Diego, California, USA.

Edward Murphy (E)

Biometrics, Travere Therapeutics, Inc., San Diego, California, USA.

Kaijun Wang (K)

Biometrics, Travere Therapeutics, Inc., San Diego, California, USA.

Jula Inrig (J)

Nephrology, Travere Therapeutics, Inc., San Diego, California, USA.

Radko Komers (R)

Nephrology, Travere Therapeutics, Inc., San Diego, California, USA.

Classifications MeSH