CONCOMITANT SPARSENTAN AND SODIUM-GLUCOSE COTRANSPORTER-2 INHIBITORS (SGLT2is) IN PATIENTS WITH IMMUNOGLOBULIN A NEPHROPATHY (IgAN) IN THE PROTECT OPEN-LABEL EXTENSION (OLE)

E-Poster

https://storage.unitedwebnetwork.com/files/1099/438357534c28d951ab3d87fdef045646.pdf

Abstract Title

First Name *

Radko

Last Name *

Komers

Co-author 1

Laura Kooienga lkooienga@cokidneycare.com Colorado Kidney Care Research Division Denver

Co-author 2

Robert Malecki robert.malecki@aol.pl Międzyleski Specialist Hospital Department of Nephrology Warsaw

Co-author 3

Alex Mercer alex.mercer@travere.com JAMCO Pharma Consulting N/A Stockholm

Co-author 4

Nuhira Ahmed Masthan Ahmed Nuhira.Masthan@travere.com Travere Therapeutics, Inc. Biostatistics San Diego

Co-author 5

Priscila Preciado Priscila.preciado@travere.com Travere Therapeutics, Inc. Clinical Development, Nephrology San Diego

Co-author 6

Co-author 7

Co-author 8

Co-author 9

Co-author 10

Co-author 11

Co-author 12

Co-author 13

Co-author 14

Co-author 15

Introduction

Sparsentan (SPAR) is a novel, nonimmunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist (DEARA). In the ongoing PROTECT trial SPAR is compared to irbesartan in patients with IgAN. SGLT2is may slow disease progression in IgAN as suggested in subgroup analyses from DAPA-CKD and EMPA-KIDNEY. Combined DEARA and SGLT2i therapy may provide additional kidney-protective effects with unknown adverse events. Concomitant treatment with an SGLT2i was prohibited during the PROTECT double-blind (DB) period; however, SGLT2is are allowed in the PROTECT OLE. We report the early clinical experience of SGLT2is added to ongoing SPAR treatment in patients with IgAN enrolled in the PROTECT OLE.

Methods

Patients who completed the PROTECT DB period and met eligibility criteria were enrolled in the PROTECT OLE. All patients received SPAR with a target dose of 400 mg/day. Investigators, at their discretion, could initiate concomitant SGLT2i treatment at any time during the OLE. Body weight, systolic and diastolic blood pressure, and urine protein-to-creatinine ratio (based on 24-hour urine sample) were evaluated at baseline and at weeks 12, 24, 36, and 48 after baseline. Baseline was defined as the OLE visit closest to SGLT2i start (ie, before or <14 days after). Treatment-emergent adverse events (TEAEs) were examined.

Results

At data cutoff, 39 patients (11 female) had received SPAR and an add-on SGLT2i in the OLE. Mean (SD) age was 44.2 (11.11) years. Median (IQR) time from OLE start to SGLT2i start was 36 (13-51) weeks. Summary data for selected variables are shown in the Table. Twenty-six (67%) patients had TEAEs; the most common (>5% of patients) were hyperkalemia (n=5 [13%]), COVID-19 (n=4 [10%]), and hypertension (n=3 [8%]). Five patients discontinued the OLE, including 2 who initially discontinued the SGLT2i; 2 patients discontinued the SGLT2i but remained in the OLE receiving SPAR.

Conclusions

Clinical experience to date during the PROTECT OLE shows that an SGLT2i added to a stable dose of SPAR appears to be generally well tolerated. Data are consistent with an additive benefit on proteinuria. A randomized substudy within the OLE is further investigating SPAR plus SGLT2i combined treatment.

This abstract was also submitted for the American Society of Nephrology (ASN) Kidney Week 2023 congress.

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