Menu
Recruiting NCT07224776

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

Phase I Interventional Proteinuric Renal Disease Proteinuric Kidney Disease Proteinuria Proteinuria in Nephrotic Range

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sparsentan, No sparsentan.
Who it may be relevant to
Registry conditions: Proteinuric Renal Disease, Proteinuric Kidney Disease, Proteinuria, Proteinuria in Nephrotic Range. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

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

Primary outcome measures

  • Change in urine to protein creatinine ratio (UPCR) [Time frame: 8 weeks]
Secondary outcome measures (2)
  • VSPI discontinuation or interruption [Time frame: 8 weeks]
  • Resolution of Proteinuria [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Brigham and Women's Hospital — Boston

Identifiers

NCT: NCT07224776 · 25-683

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗