Brigham and Women's Hospital
Single-center, open-label, two-stage pilot study examining the efficacy and safety of sparsentan for reducing high-grade proteinuria among patients with cancer who receive vascular endothelial growth factor inhibitors
Inclusion Criteria: 1. Adults (≥ 18 years old) with active malignancy who are currently treated with VSPIs 2. New high-grade proteinuria, defined as ≥ 2+ proteinuria on dipstick or a calculated urinary protein-to-creatinine ratio ≥ 1.0 g/g 3. Able to provide written inform consent Exclusion Criteria: 1. Estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73m2 2. Baseline high grade proteinuria ≥ 2+ proteinuria on dipstick or a calculated urinary protein-to creatinine ratio or microalbumin-to-creatinine ≥ 1.0 g/g prior to VSPI initiation 3. Acute kidney injury defined as serum creatin…
Participants will receive sparsentan 200 mg daily for 2 weeks, and will then titrate up to a target of 400 mg daily. Safety and feasibility will be assessed. The mean percent change in urine protein to creatinine ratio will be assessed from screening to week 8, and compared to historical controls not treated with sparsentan.
Historical controls who did not receive sparsentan, and are matched to patients who are treated with sparsentan
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