Actively Recruiting
Safety and Activity Study of Sparsentan for Patients With Incident and Recurrent Immunoglobulin A Nephropathy
Led by University of Leicester · Updated on 2026-06-03
24
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Leicester
Lead Sponsor
T
Travere Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and activity of sparsentan for treating adult patients with biopsy-confirmed immunoglobulin A nephropathy (IgAN), including newly diagnosed patients who have not received prior ACEI or ARB therapy (Cohort A) and patients with recurrent IgAN after kidney transplantation (Cohort B). This open-label, multi-center trial aims to explore sparsentan's potential to protect kidney function over an extended period. In Cohort A, patients will start sparsentan at 200 mg daily, increasing to a target dose of 400 mg daily after two weeks if tolerated, with dose adjustments allowed to maintain the highest tolerable dose. Treatment will continue for 110 weeks, followed by a 4-week off-treatment follow-up. Cohort B patients will be randomly assigned to receive sparsentan plus standard care for 48 weeks or standard care alone for 24 weeks before adding sparsentan for the remaining 24 weeks, then followed by a 4-week follow-up. Additional antihypertensive treatments are allowed except for ACEIs, ARBs, aldosterone blockers, or aliskiren. Participants will undergo assessments including urine protein excretion, estimated and measured glomerular filtration rate (GFR), kidney biopsy analysis using the Oxford Classification, MRI for kidney and heart function, bioimpedance for body water, and quality of life evaluations. Safety will be monitored through adverse events, lab tests, and vital signs. The primary outcome is urine protein/creatinine ratio at Week 36, with secondary outcomes assessing kidney function, proteinuria changes, and safety over up to 114 weeks.
CONDITIONS
Brief Title
A Study of the Safety and Activity of Sparsentan for the Treatment of Patients With Immunoglobulin A Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide signed informed consent
- Able to understand written and spoken English
- Male or female aged 18 years or older
- Diagnosed with biopsy-proven immunoglobulin A nephropathy within the last 6 months (Cohort A) or diagnosis of recurrent IgAN from kidney transplant biopsy within last 6 months (Cohort B)
- Urine total protein value of at least 0.5 g/day (Cohort A) or UPCR at least 50 mg/mmol (Cohort B)
- Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2 (Cohort A) or at least 25 mL/min/1.73 m2 (Cohort B)
- No prior treatment with ACE inhibitors or angiotensin receptor blockers for IgAN within the last 12 months (Cohort A)
- Stable standard of care immunosuppressive therapy including tacrolimus for kidney transplant patients (Cohort B)
- Systolic blood pressure between 100 and 150 mmHg and diastolic blood pressure between 60 and 100 mmHg
- Women of childbearing potential must agree to use highly reliable contraception methods from 7 days before first dose until 90 days after last dose
- Negative pregnancy tests at screening visits for women of childbearing potential
You will not qualify if you...
- IgAN secondary to other conditions such as systemic lupus erythematosus or liver cirrhosis
- Rapidly progressive glomerulonephritis or rapid decline in kidney function
- History of type 1 diabetes, uncontrolled type 2 diabetes, or high blood glucose at screening
- Prior organ transplantation except corneal transplants
- Use of prohibited medications including ACE inhibitors, ARBs, aldosterone blockers, or aliskiren
- Recent or ongoing immunosuppressive treatment beyond allowed limits
- History of heart failure or recent serious cardiovascular events
- Significant liver disease or elevated liver enzymes
- Recent malignancy except certain treated skin or cervical cancers
- Low blood counts or high potassium levels at screening
- History of alcohol or drug use disorder
- Allergic reaction or hypersensitivity to sparsentan or similar drugs
- Pregnancy, breastfeeding, or plans to become pregnant during the trial
- Participation in another investigational drug trial within 28 days prior to screening
- Any medical conditions or lab abnormalities that may interfere with safe participation or evaluation of sparsentan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 110 weeks
Participants receive sparsentan once daily, starting at 200 mg/day for the first 2 weeks, then increasing to a target dose of 400 mg/day if tolerated. Dose adjustments may be made to the maximum tolerated dose. Treatment lasts for a total of 110 weeks. Additional antihypertensive agents may be used except ACE inhibitors, aldosterone blockers, aliskiren, or ARBs.
Regular visits throughout treatment for safety assessments and dose adjustments
Duration - 4 weeks
Participants are monitored for 4 weeks after stopping sparsentan treatment. During this time, treatment is at the discretion of the investigator.
1 to 2 visits during follow-up
Trial Site Locations
Total: 6 locations
1
Cambridge University Hospitals NHS Trust
Cambridge, England, United Kingdom
Actively Recruiting
2
Northern Care Alliance NHS Foundation Trust - Salford Royal
Salford, England, United Kingdom
Actively Recruiting
3
Royal Infirmary of Edinburgh & Western General Hospital
Edinburgh, Scotland, United Kingdom
Actively Recruiting
4
University Hospital of wales
Cardiff, Wales, United Kingdom, CF14 4XW
Actively Recruiting
5
Leicester General Hospital, University Hospitals of Leicester NHS Trust
Leicester, United Kingdom, LE5 4PW
Actively Recruiting
6
King's College Hospital
London, United Kingdom
Actively Recruiting
Research Team
J
Justyna Szklarzewicz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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