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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07224776
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Proteinuria
  • Proteinuria in Nephrotic Range
  • Proteinuric Kidney Disease
  • Proteinuric Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • sparsentan — DRUG
    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.
  • No sparsentan — DRUG
    Historical controls who did not receive sparsentan, and are matched to patients who are treated with sparsentan

Study Details

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

Key Dates

Start date
Jun 10, 2026
Status verified
May 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment with sparsentan, an endothelin-1 antagonist
    Participants will receive sparsentan 200 mg daily for 2 weeks, and will then titrate up to a target of 400 mg daily. After the Week 8 visit, patients will return to standard-of-care. We will compare the mean percent change in urine protein to creatinine ratio in patients treated with sparsentan versus historical controls who did not receive sparsentan.
  • Placebo Comparator: Historical controls with high-grade proteinuria not treated with sparsentan
    Participants must meet all eligibility criteria, but did not receive sparsentan. Historical controls will be matched based on age, sex, race, stage and cancer type

Primary Outcome Measure

Change in urine to protein creatinine ratio (UPCR) [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Shruti Gupta
[email protected]
5712366626
Sophia L Wells
[email protected]
330-802-5405
Api Chewcharat, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Brigham and Women's Hospital· Boston, MA

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