NCT07224776招募中1 期
Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in urine to protein creatinine ratio (UPCR)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥ 18 years old) with active malignancy who are currently treated with VSPIs
- •New high-grade proteinuria, defined as ≥ 2+ proteinuria on dipstick or a calculated urinary protein-to-creatinine ratio ≥ 1.0 g/g
- •Able to provide written inform consent
排除标准
- •Estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2
- •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
- •Acute kidney injury defined as serum creatinine at least 1.5 times above the most proximal serum creatinine prior to VSPIs initiation
- •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.
- •Any potassium value >5 mEq/L in the 14 days preceding high-grade proteinuria
- •History of organ transplantation, with the exception of corneal transplants.
- •History of congestive heart failure (New York Heart Association Class II-IV)
- •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.
- •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.
- •Body weight <50 kg at screening
- •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
- •Concomitant use of the following medications:
- •Inhibitors of endothelin system such as ambrisentan, bosentan, macitentan
- •Potassium-sparing diuretics such as amiloride, triamterene
- •Antiarrhythmic medications such as amiodarone, digoxin
- •Weight loss medications such as orlistat or amphetamine derivative agents
- •St. John's wort or other hypericum-derived products
- •Strong CYP3A inhibitors such as ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, ritonavir- or cobicistat-boosted regimens, boceprevir, telaprevir, conivaptan, mibefradil
- •Pregnant or breastfeeding
- •Concurrent participation in a study with an alternative experimental therapy that may interact with sparsentan
- •Any condition that, in the view of the principal investigator, might place the patient at increased risk or compromise the integrity of the study
- •Conflict with other study
研究组 & 干预措施
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.
干预措施: sparsentan (Drug)
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
干预措施: No sparsentan (Drug)
结局指标
主要结局
Change in urine to protein creatinine ratio (UPCR)
时间窗: 8 weeks
The geometric mean percent change in UPCR from screening day to Week 8
次要结局
- VSPI discontinuation or interruption(8 weeks)
- Resolution of Proteinuria(8 weeks)
研究者
Shruti Gupta
Director of Onconephrology
Brigham and Women's Hospital
研究点 (1)
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