A Study of the Safety and Activity of Sparsentan for the Treatment of Patients With Immunoglobulin A Nephropathy

Sponsor
University of Leicester
Study ID
NCT04663204
Phase
PHASE2
Status
Recruiting
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Conditions

  • Autoimmune Diseases
  • Glomerulonephritis
  • Glomerulonephritis, IGA
  • Immune System Diseases
  • Immunoglobulin A Nephropathy
  • Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

To determine the nephroprotective potential of treatment with sparsentan in (1: Cohort A) patients newly-diagnosed with immunoglobulin A nephropathy (IgAN) (ie, incident patients) who have not received prior angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) therapy, and in (2: Cohort B) patients with recurrent IgAN following kidney transplantation.

Key Dates

Start date
Dec 10, 2020
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sparsentan
    Sparsentan will be administered once daily, starting at a dose of 200 mg (two 100 mg oral capsules) for the first 2 weeks of the study. Patients who tolerate the initial dose of 200 mg after 2 weeks will increase their dose to 400 mg (one 400 mg tablet). Patients who do not tolerate the target dose will have their dose reduced back to 200 or 100 mg/day; throughout the study, patients will be maintained on the maximum allowed dose of sparsentan they can tolerate. All patients will be treated with sparsentan for a total of 110 weeks.

Primary Outcome Measure

Urine protein/creatinine ratio (UP/C) at Week 36 [ Time Frame: Week 36 ]

Central Contacts

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