[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610222":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":63,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":26,"eligibilityCriteria":74,"healthyVolunteers":71,"sex":75,"minAge":76,"maxAge":26,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":94,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment with sparsentan, an endothelin-1 antagonist","ACTIVE_COMPARATOR","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.",[13],"Drug: sparsentan",{"label":15,"type":16,"description":17,"interventionNames":18},"Historical controls with high-grade proteinuria not treated with sparsentan","PLACEBO_COMPARATOR","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",[19],"Drug: No sparsentan",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"No sparsentan","Historical controls who did not receive sparsentan, and are matched to patients who are treated with sparsentan",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Shruti Gupta, MD, MPH","CONTACT","5712366626","sgupta21@bwh.harvard.edu",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Api Chewcharat, MD, MPH","857-930-5167","achewcharat@bwh.harvard.edu",[42],{"facility":5,"status":26,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Boston","Massachusetts","02115","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-71.05977,42.35843,{"lat":52,"lon":51},[55,57,61],{"name":56,"role":34,"phone":35,"phoneExt":26,"email":36},"Shruti Gupta",{"name":58,"role":34,"phone":59,"phoneExt":26,"email":60},"Sophia L Wells","330-802-5405","swells8@bwh.harvard.edu",{"name":38,"role":62,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":62,"investigatorFullName":56,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Director of Onconephrology",[66],{"name":67,"class":68},"Travere Therapeutics, Inc.","INDUSTRY","100610222","phase-1-sparsentan-for-the-treatment-of-vegf-signaling-pathway-inhibitor-associated-proteinuria-100610222",false,"NCT07224776","Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria","Inclusion Criteria:\n\n1. Adults (≥ 18 years old) with active malignancy who are currently treated with VSPIs\n2. New high-grade proteinuria, defined as ≥ 2+ proteinuria on dipstick or a calculated urinary protein-to-creatinine ratio ≥ 1.0 g\u002Fg\n3. Able to provide written inform consent\n\nExclusion Criteria:\n\n1. Estimated glomerular filtration rate (eGFR) \\\u003C 45 ml\u002Fmin\u002F1.73m2\n2. Baseline high grade proteinuria ≥ 2+ proteinuria on dipstick or a calculated urinary protein-to creatinine ratio or microalbumin-to-creatinine ≥ 1.0 g\u002Fg prior to VSPI initiation\n3. Acute kidney injury defined as serum creatinine at least 1.5 times above the most proximal serum creatinine prior to VSPIs initiation\n4. 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.\n5. Any potassium value \\>5 mEq\u002FL in the 14 days preceding high-grade proteinuria\n6. History of organ transplantation, with the exception of corneal transplants.\n7. History of congestive heart failure (New York Heart Association Class II-IV)\n8. History of clinically significant cerebrovascular disease (transient ischemic attack or stroke) and\u002For 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.\n9. Jaundice, hepatitis, or known hepatobiliary disease (excluding asymptomatic cholelithiasis), or alanine aminotransferase and\u002For aspartate aminotransferase \\>2 times the upper limit of the normal at screening.\n10. Body weight \\\u003C50 kg at screening\n11. Unable to hold renin-angiotensin-aldosterone system (RAAS) inhibitors such as angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), spironolactone, eplerenone, aliskiren, aldosterone blockers during run-in period\n12. Concomitant use of the following medications:\n\n    1. Inhibitors of endothelin system such as ambrisentan, bosentan, macitentan\n    2. Potassium-sparing diuretics such as amiloride, triamterene\n    3. Antiarrhythmic medications such as amiodarone, digoxin\n    4. Weight loss medications such as orlistat or amphetamine derivative agents\n    5. St. John's wort or other hypericum-derived products\n    6. Strong CYP3A inhibitors such as ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, ritonavir- or cobicistat-boosted regimens, boceprevir, telaprevir, conivaptan, mibefradil\n13. Pregnant or breastfeeding\n14. Concurrent participation in a study with an alternative experimental therapy that may interact with sparsentan\n15. Any condition that, in the view of the principal investigator, might place the patient at increased risk or compromise the integrity of the study\n16. Conflict with other study","ALL","18 Years",{"count":78,"type":79},20,"ESTIMATED","INTERVENTIONAL",[82],"PHASE1","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",[85,86,87,88],"Proteinuric Renal Disease","Proteinuric Kidney Disease","Proteinuria","Proteinuria in Nephrotic Range",[90,91,92,93],"vascular endothelial growth factor inhibitors","cancer","proteinuria","endothelin-1 antagonist","NOT_YET_RECRUITING","2026-05-14",{"date":97,"type":98},"2026-05-18","ACTUAL",{"date":100,"type":79},"2026-06-10",{"date":102,"type":79},"2028-12-01",{"name":5,"class":6},1]