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

NCT07224776 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-18

No results posted yet for this study

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

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

Interventions

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

Sponsors & Collaborators

  • Travere Therapeutics, Inc.

    collaborator INDUSTRY
  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-10
Primary Completion
2026-12-01
Completion
2028-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07224776 on ClinicalTrials.gov