Trials / Not Yet Recruiting
Not Yet RecruitingNCT07224776
Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Brigham and Women's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sparsentan | 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. |
| DRUG | No sparsentan | Historical controls who did not receive sparsentan, and are matched to patients who are treated with sparsentan |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2026-12-01
- Completion
- 2028-12-01
- First posted
- 2025-11-05
- Last updated
- 2026-02-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07224776. Inclusion in this directory is not an endorsement.