Not Yet RecruitingPhase 1

Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria

United States20 participantsStarted 2026-03-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults (≥ 18 years old) with active malignancy who are currently treated with VSPIs
✓. New high-grade proteinuria, defined as ≥ 2+ proteinuria on dipstick or a calculated urinary protein-to-creatinine ratio ≥ 1.0 g/g
✓. Able to provide written inform consent

Exclusion criteria

✕. Estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73m2
✕. 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
✕. Acute kidney injury defined as serum creatinine at least 1.5 times above the most proximal serum creatinine prior to VSPIs initiation
✕. History of allergic reactions or angioedema to any angiotensin receptor blocker (ARB) or ERA, including sparsentan or irbesartan, or has a hypersensitivity to any of the excipients in the study medications.
✕. Any potassium value \>5 mEq/L in the 14 days preceding high-grade proteinuria
✕. History of organ transplantation, with the exception of corneal transplants.
✕. History of congestive heart failure (New York Heart Association Class II-IV)
✕. History of clinically significant cerebrovascular disease (transient ischemic attack or stroke) and/or coronary artery disease (hospitalization for myocardial infarction or unstable angina, new onset of angina with positive functional tests, coronary angiogram revealing stenosis, or a coronary revascularization procedure) within 6 months prior to screening.

What they're measuring

Change in urine to protein creatinine ratio (UPCR)

Timeframe: 8 weeks

Trial details

NCT IDNCT07224776

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Shruti Gupta, MD, MPH

5712366626 sgupta21@bwh.harvard.edu

View on ClinicalTrials.gov More Proteinuric Renal Disease trials