Abstract: TH-PO0468
Sparsentan (SPAR) Safety Data from an Early Access Program (EAP) in IgAN
Session Information
- Glomerular Diseases: Clinical, Outcomes, and Therapeutics Research - IgAN
October 22, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Popov, Tamara, CSL, Glattbrugg, Switzerland
- Latus, Joerg, Robert Bosch GmbH, Gerlingen-Schillerhöhe, BW, Germany
- Alberici, Federico, Universita degli Studi di Brescia, Brescia, Lombardy, Italy
- Csomor, Philipp, CSL, Glattbrugg, Switzerland
- Baquero, Elbalejandra, CSL, Glattbrugg, Switzerland
Background
SPAR, a dual endothelin angiotensin receptor antagonist approved for IgAN, showed significant proteinuria reduction and preservation of kidney function vs irbesartan with a comparable safety profile in the phase 3 PROTECT study. To better characterize real-world use, we analyzed safety data from patients (pts) receiving SPAR in an EAP.
Methods
Eligible adults with primary IgAN from 15 countries received SPAR via the EAP between Mar 2, 2023 and Apr 28, 2026. Here we report safety data from the cohort.
Results
At data cut-off, 452 pts had received ≥1 dose of SPAR. Median treatment duration whilst in the EAP was 9 months (interquartile range 6–15). Pts could continue treatment with the commercial drug past the end of the EAP. 269 adverse events (AEs) were reported; 99 (21.9 %) pts had ≥1 AE; 80 serious AEs were reported across 34 pts (7.5%). The most frequently affected ‘System Organ Classes’ were general disorders and administration site conditions (14.5%), investigations (13.4%), vascular disorders (11.9%), and injury, poisoning and procedural complications (10.8%). The most common AEs (≥5 events) were hypotension [HT] (9.7%), hyperkalemia [HK] (4.1%), dizziness (3.7%), renal impairment and proteinuria (2.2% each), fatigue and edema (1.8% each).
HT, including orthostatic HT, occurred in 26 (5.8%) and led to treatment discontinuation in 4 (0.9%). HK or blood potassium increase occurred in 10 (4.5%), with dose reduction in 3. Dizziness occurred in 9 (2.0%), leading to discontinuation in 2 (0.45%). Renal events (renal impairment or failure; creatinine abnormalities) occurred in 8 (1.8%) and led to treatment withdrawal in 2 (0.45%). 22 hepatic-associated events were reported in 9 (2.0%), of which 15 events in 5 pts (1.1%) were classed as serious. Most serious hepatic-associated events were laboratory based (12/15), with 11 reported as recovered or recovering; discontinuation due to hepatic events occurred in 6 (1.3%). Edema occurred in 5 (1.1%), including one serious case associated with congestive heart failure requiring hospitalization that led to discontinuation. 2 fatal events occurred: 1 suicide and one 1 myocardial infarction occurring 3 days after SPAR initiation, following emergency admission for acute coronary symptoms (no causality assessment was provided by the reporter).
Conclusion
SPAR demonstrates a favorable real-world safety profile with no new or unexpected safety concerns identified.
Funding
- Commercial Support – CSL