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Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

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

NCT07224776•Brigham and Women's Hospital

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 creatinine at least 1.5 times above the most proximal serum creatinine prior to VSPIs initiation
•4. 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.
•5. Any potassium value \>5 mEq/L in the 14 days preceding high-grade proteinuria
•6. History of organ transplantation, with the exception of corneal transplants.
•7. History of congestive heart failure (New York Heart Association Class II-IV)
•8. 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.
•9. Jaundice, hepatitis, or known hepatobiliary disease (excluding asymptomatic cholelithiasis), or alanine aminotransferase and/or aspartate aminotransferase \>2 times the upper limit of the normal at screening.
•10. Body weight \<50 kg at screening
+12 more criteria

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

March 1, 2026

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2028

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Proteinuric Renal DiseaseProteinuric Kidney DiseaseProteinuriaProteinuria in Nephrotic Range

Interventions

sparsentan

DRUG

No sparsentan

DRUG

Contacts

Shruti Gupta, MD, MPH

CONTACT

5712366626 sgupta21@bwh.harvard.edu

Api Chewcharat, MD, MPH

CONTACT

857-930-5167 achewcharat@bwh.harvard.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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