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โ† Trials
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Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria

RecruitingPhase 1Ages 18 Years - anyAllBrigham and Women's Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Adults (โ‰ฅ 18 years old) with active malignancy who are currently treated with VSPIs 2. New high-grade proteinuria, defined as โ‰ฅ 2+ proteinuria on dipstick or a calculated urinary protein-to-creatinine ratio โ‰ฅ 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 โ‰ฅ 2+ proteinuria on dipstick or a calculated urinary protein-to creatinine ratio or microalbumin-to-creatinine โ‰ฅ 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 11. 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 12. Concomitant use of the following medications: 1. Inhibitors of endothelin system such as ambrisentan, bosentan, macitentan 2. Potassium-sparing diuretics such as amiloride, triamterene 3. Antiarrhythmic medications such as amiodarone, digoxin 4. Weight loss medications such as orlistat or amphetamine derivative agents 5. St. John's wort or other hypericum-derived products 6. Strong CYP3A inhibitors such as ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, ritonavir- or cobicistat-boosted regimens, boceprevir, telaprevir, conivaptan, mibefradil 13. Pregnant or breastfeeding 14. Concurrent participation in a study with an alternative experimental therapy that may interact with sparsentan 15. Any condition that, in the view of the principal investigator, might place the patient at increased risk or compromise the integrity of the study 16. Conflict with other study
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What it tests

  • sparsentan
  • No sparsentan
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Where

1 site
Brigham and Women's Hospital
Boston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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