This was a 28-week, open-label, multicenter, single-group Phase 2 exploratory study to determine the safety and effect of sparsentan in participants with IgAN who are at risk of disease progression to kidney failure despite being on both stable RAASi and SGLT2 inhibitor treatment for at least 12 weeks prior to study entry
This was a 28-week, open-label, multicenter, single-group Phase 2 exploratory study to determine the safety and effect of sparsentan in participants with Immunoglobulin A Nephropathy (IgAN) who are at risk of disease progression to kidney failure (KF) despite being on both stable renin angiotensin aldosterone system inhibitor (RAASi) and sodium glucose cotransporter-2 (SGLT2) inhibitor treatment for at least 12 weeks prior to study entry. Participants who provided written informed consent were assessed for eligibility and underwent baseline evaluations including clinical laboratory tests. Per the eligibility criteria, all participants were required to be on a stable dose(s) of angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) and on a stable dose of a SGLT2 inhibitor at screening and continued their stable treatments through the screening period. Eligible participants discontinued ACEI and/or ARB therapy the day before the Day 1 visit and remained on stable SGLT2 inhibitor dosing for the duration of the study. Study intervention was administered daily for a treatment period of 24 weeks with study visits conducted at weeks 2-, 4-, 12-, and 24- following Day 1. Following the 24-week treatment period, study intervention was discontinued for 4 weeks and standard of care RAASi treatment resumed, with a safety visit at Week 28.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Target dose of 400 mg daily
Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24
The change from baseline in UA/C at Week 24 based on first morning void (FMV) samples
Time frame: Week 24
UA/C <0.2 g/g at Week 24
Achievement of UA/C of \<0.2 g/g at Week 24 based on FMV samples
Time frame: Week 24
30% Reduction From Baseline in UA/C at Week 24
Achievement of 30% reduction from baseline in UA/C at Week 24 based on FMV samples
Time frame: Week 24
50% Reduction From Baseline in UA/C at Week 24
Achievement of 50% reduction from baseline in UA/C at Week 24 based on FMV samples
Time frame: Week 24
Change in Urine Protein-to-creatinine Ratio (UP/C) at Week 24
The change from baseline in UP/C at Week 24 based on FMV samples
Time frame: Week 24
Estimated Glomerular Filtration Rate (eGFR)
Change from baseline estimated glomerular filtration rate at 24 weeks
Time frame: Week 24
Systolic Blood Pressure (BP) at Week 24
The change from baseline in systolic BP at Week 24
Time frame: Week 24
Change in Diastolic Blood Pressure (BP)
The change from baseline in diastolic BP at Week 24
Time frame: Week 24
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