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Идёт набор NCT07224776

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

Фаза I С лечением Proteinuric Renal Disease Proteinuric Kidney Disease Proteinuria Proteinuria in Nephrotic Range

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: sparsentan, No sparsentan.
Кому может быть актуально
Состояния в реестре: Proteinuric Renal Disease, Proteinuric Kidney Disease, Proteinuria, Proteinuria in Nephrotic Range. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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

Вмешательства

  • Препарат 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.
  • Препарат No sparsentan
    Historical controls who did not receive sparsentan, and are matched to patients who are treated with sparsentan

Первичные конечные точки

  • Change in urine to protein creatinine ratio (UPCR) [Срок оценки: 8 weeks]
Вторичные конечные точки (2)
  • VSPI discontinuation or interruption [Срок оценки: 8 weeks]
  • Resolution of Proteinuria [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT07224776 · 25-683

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗