Trial results for a Phase 2 study investigating sparsentan in participants with Immunoglobulin A Nephropathy (IgAN) were posted on ClinicalTrials.gov on 2025-11-20. The study showed a least squares mean change in Urine Albumin-creatinine Ratio (UA/C) of -55.78% at Week 24 in patients receiving sparsentan.
Background
Sparsentan was investigated in this study for its effect in participants with Immunoglobulin A Nephropathy (IgAN). The trial specifically focused on patients already at risk of disease progression to kidney failure despite being on stable RAASi and SGLT2 inhibitor treatment.
Trial design
The study (NCT05856760) was a Phase 2, open-label, multicenter, single-group exploratory study that enrolled 48 participants. It investigated the safety and effect of sparsentan in combination with SGLT2 inhibition in participants with Immunoglobulin A Nephropathy (IgAN). Participants were at risk of disease progression to kidney failure despite being on stable RAASi and SGLT2 inhibitor treatment for at least 12 weeks prior to study entry. The study duration was 28 weeks.
Key results
The trial results showed several changes in key measurements at Week 24:
- The least squares mean change in Urine Albumin-creatinine Ratio (UA/C) was -55.78% for the sparsentan group.
- 31% of participants achieved a UA/C of less than 0.2 g/g.
- 77% of participants achieved a 30% reduction from baseline in UA/C.
- 51% of participants achieved a 50% reduction from baseline in UA/C.
- The least squares mean change in Urine Protein-to-creatinine Ratio (UP/C) was -45.20%.
- The geometric mean change in Estimated Glomerular Filtration Rate (eGFR) was -2.0 mL/min/1.73 square meter.
- The least squares mean change in Systolic Blood Pressure (BP) was -3.4 mmHg.
- The least squares mean change in Diastolic Blood Pressure (BP) was -4.6 mmHg.
What this means
The results from this Phase 2 exploratory study suggest that sparsentan, when added to stable RAASi and SGLT2 inhibitor treatment, may offer additional benefits for patients with Immunoglobulin A Nephropathy (IgAN) at risk of disease progression. The observed reductions in Urine Albumin-creatinine Ratio (UA/C) and Urine Protein-to-creatinine Ratio (UP/C) indicate a potential positive impact on proteinuria, a key marker of kidney disease progression. The changes in blood pressure also suggest a systemic effect. These findings warrant further investigation in larger clinical trials to confirm the long-term efficacy and safety profile of this combination therapy.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05856760, titled "A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN," were posted on 2025-11-20 on clinicaltrials.gov.