New hope for cancer patients: Kidney-Sparing drug shows promise
NCT ID NCT07224776
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study tests a drug called sparsentan to reduce high levels of protein in the urine (proteinuria) caused by certain cancer treatments. About 20 adults with cancer who are taking VEGF inhibitors and have developed proteinuria will receive sparsentan for 8 weeks. The goal is to see if the drug can lower protein levels and help patients stay on their cancer therapy without kidney damage.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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