Proteinuric Renal DiseasePhase 1NCT07224776
Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria
A Phase 1 study testing sparsentan and No sparsentan in people with Proteinuric Renal Disease and Proteinuric Kidney Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proteinuric Renal Disease, Proteinuric Kidney Disease, Proteinuria
- What is being tested?
- sparsentan and No sparsentan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2026to 1 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Shruti Gupta, 571-236-6626, sgupta21@bwh.harvard.edu
Sophia L Wells, 330-802-5405, swells8@bwh.harvard.edu
About this study
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
- Conditions
- Proteinuric Renal Disease, Proteinuric Kidney Disease, Proteinuria, Proteinuria in Nephrotic Range
- Being tested
- sparsentan, No sparsentan
- Keywords
- vascular endothelial growth factor inhibitors, cancer, proteinuria, endothelin-1 antagonist
- Medical subject headings
- Proteinuria, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sparsentanDrug
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.
No sparsentanDrug
Historical controls who did not receive sparsentan, and are matched to patients who are treated with sparsentan
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: sparsentan |
| 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 Receives: Drug: No sparsentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine to protein creatinine ratio (UPCR)
The geometric mean percent change in UPCR from screening day to Week 8
Measured: 8 weeks
Secondary outcomes (2)
VSPI discontinuation or interruption
Incidence of VSPI discontinuation or interruption in the 8 weeks following onset of high-grade proteinuria
Measured: 8 weeks
Resolution of Proteinuria
Incidence of resolution of high-grade proteinuria, defined as recovery of UPCR < 0.5 g/g in the 8 weeks following onset of high-grade proteinuria
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start10 Jul 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proteinuric Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Travere Therapeutics, Inc.
- Responsible party
- Principal investigator, Shruti Gupta, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224776
- Sponsor's protocol ID
- 25-683
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small, pilot study with patients with cancer receiving a specific cancer treatment.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria
- ClinicalTrials.gov ID
- NCT07224776
- Acronym / sponsor ID
- 25-683
- Conditions
- Proteinuric Renal Disease, Proteinuric Kidney Disease, Proteinuria, Proteinuria in Nephrotic Range
- Keywords
- vascular endothelial growth factor inhibitors, cancer, proteinuria, endothelin-1 antagonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Travere Therapeutics, Inc.
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 5 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with sparsentan, an endothelin-1 antagonist | Active comparator | Drug: sparsentanParticipants 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. |
| Historical controls with high-grade proteinuria not treated with sparsentan | Placebo comparator | Drug: No sparsentanParticipants must meet all eligibility criteria, but did not receive sparsentan. Historical controls will be matched based on age, sex, race, stage and cancer type |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sparsentanParticipants 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 | Treatment with sparsentan, an endothelin-1 antagonist |
| No sparsentanHistorical controls who did not receive sparsentan, and are matched to patients who are treated with sparsentan | Drug | Historical controls with high-grade proteinuria not treated with sparsentan |
Primary outcome
Change in urine to protein creatinine ratio (UPCR)
Time frame: 8 weeks
The geometric mean percent change in UPCR from screening day to Week 8
2 secondary outcomes
VSPI discontinuation or interruption
Time frame: 8 weeks
Resolution of Proteinuria
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No. This is a small, pilot study with patients with cancer receiving a specific cancer treatment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sparsentan and No sparsentan in people with Proteinuric Renal Disease and Proteinuric Kidney Disease, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shruti Gupta, MD, MPH (5712366626, sgupta21@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urine to protein creatinine ratio (UPCR) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.