Sparsentan Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Sparsentan comprises 15 peer-reviewed publications across 8 journals, 3 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Glomerulosclerosis, Focal Segmental, Glomerulonephritis, IGA, and Kidney Diseases. Most recent publication: Antiproteinuric Effect of Sparsentan in Patients with Genetic-Associated FSGS Enrolled in the DUPLEX Trial., Clin J Am Soc Nephrol, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. DUET: A Phase 2 Study Evaluating the Efficacy and Safety of Sparsentan in Patients with FSGS.
    Trachtman H, Nelson P, Adler S, et al. · J Am Soc Nephrol · 2019
    PubMed: PMID 30361325 · NCT01613118 (DUET) · Glomerulosclerosis, Focal Segmental
  2. Sparsentan for Focal Segmental Glomerulosclerosis in the DUET Open-Label Extension: Long-term Efficacy and Safety.
    Campbell KN, Gesualdo L, Murphy E, et al. · Kidney Med · 2024
    PubMed: PMID 38831932 · NCT01613118 (DUET) · Glomerulosclerosis, Focal Segmental
  3. Antiproteinuric Effect of Sparsentan in Patients with Genetic-Associated FSGS Enrolled in the DUPLEX Trial.
    Yee J, Gong W, Inrig J, et al. · Clin J Am Soc Nephrol · 2026
    PubMed: PMID 41433094 · NCT03493685 (DUPLEX) · Glomerulosclerosis, Focal Segmental
  4. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial.
    Rovin BH, Barratt J, Heerspink HJL, et al. · Lancet · 2023
    PubMed: PMID 37931634 · NCT03762850 (PROTECT) · Glomerulonephritis, IGA
  5. Treatment Approaches for Alport Syndrome.
    Rheault MN · J Am Soc Nephrol · 2026
    PubMed: PMID 40938675 · NCT05003986 (EPPIK) · Glomerulonephritis, IGA
  6. Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis.
    Rheault MN, Alpers CE, Barratt J, et al. · N Engl J Med · 2024
    PubMed: PMID 37921461 · NCT03493685 (DUPLEX) · Glomerulosclerosis, Focal Segmental
  7. Association between Complete Proteinuria Remission and Kidney Function in the Phase 3 PROTECT Trial of Sparsentan in IgA Nephropathy.
    Heerspink HJL, Rovin BH, Komers R, et al. · Clin J Am Soc Nephrol · 2026
    PubMed: PMID 41428405 · NCT03762850 (PROTECT) · Glomerulonephritis, IGA
  8. Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial.
    Heerspink HJL, Radhakrishnan J, Alpers CE, et al. · Lancet · 2023
    PubMed: PMID 37015244 · NCT03762850 (PROTECT) · Glomerulonephritis, IGA

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT03493685
DUPLEX
Glomerulosclerosis, Focal SegmentalPercentage of Participants Achieving FSGS Partial Remission Endpoint (FPRE)
Week 36
Irbesartan26.0 Percentage of participants
Sparsentan42.0 Percentage of participants
NCT03493685
DUPLEX
Glomerulosclerosis, Focal SegmentalSlope of Estimated Glomerular Filtration Rate (eGFR)
From Day 1 to Week 108
Irbesartan-5.7 milliliters/minute/1.73square meter/year
Sparsentan-5.4 milliliters/minute/1.73square meter/year
NCT03762850
PROTECT
Glomerulonephritis, IGAPercent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36
Baseline (Day 1) and at Week 36
Irbesartan-15.05 Percent change
Sparsentan-49.77 Percent change

Publications by year

2011–2026: 15 publications.

2011
1
2019
1
2022
2
2023
4
2024
3
2025
1
2026
3

Publications by indication

Glomerulosclerosis, Focal Segmental (9)

  • Antiproteinuric Effect of Sparsentan in Patients with Genetic-Associated FSGS Enrolled in the DUPLEX Trial.
    Clin J Am Soc Nephrol · 2026 · PMID 41433094 · NCT03493685
  • Interventions for idiopathic steroid-resistant nephrotic syndrome in children.
    Cochrane Database Syst Rev · 2025 · PMID 40337980 · NCT01613118
  • Sparsentan for Focal Segmental Glomerulosclerosis in the DUET Open-Label Extension: Long-term Efficacy and Safety.
    Kidney Med · 2024 · PMID 38831932 · NCT01613118
  • Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis.
    N Engl J Med · 2024 · PMID 37921461 · NCT03493685
  • PPAR δ Agonism Ameliorates Renal Fibrosis in an Alport Syndrome Mouse Model.
    Kidney360 · 2023 · PMID 36657027 · NCT01613118

Glomerulonephritis, IGA (5)

  • Treatment Approaches for Alport Syndrome.
    J Am Soc Nephrol · 2026 · PMID 40938675 · NCT05003986
  • Association between Complete Proteinuria Remission and Kidney Function in the Phase 3 PROTECT Trial of Sparsentan in IgA Nephropathy.
    Clin J Am Soc Nephrol · 2026 · PMID 41428405 · NCT03762850
  • Non-immunosuppressive treatment for IgA nephropathy.
    Cochrane Database Syst Rev · 2024 · PMID 38299639 · NCT03762850
  • Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial.
    Lancet · 2023 · PMID 37931634 · NCT03762850
  • Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial.
    Lancet · 2023 · PMID 37015244 · NCT03762850

Kidney Diseases (1)

  • Arterial stiffness, endothelial dysfunction and impaired fibrinolysis are pathogenic mechanisms contributing to cardiovascular risk in ANCA-associated vasculitis.
    Kidney Int · 2022 · PMID 35998848 · NCT05630612

Publications by journal

Trial-results highlights

For patients with Focal Segmental Glomerulosclerosis (FSGS), the DUPLEX study (NCT03493685) evaluated Sparsentan compared to irbesartan. The primary outcome measured was the percentage of participants achieving the FSGS Partial Remission Endpoint (FPRE) at Week 36. In the Sparsentan arm of NCT03493685, 42.0% of participants achieved FPRE. In the irbesartan arm of NCT03493685, 26.0% of participants achieved FPRE. Another key outcome was the slope of estimated Glomerular Filtration Rate (eGFR) from Day 1 to Week 108. The eGFR slope in the Sparsentan arm of NCT03493685 was -5.4 milliliters/minute/1.73square meter/year. For the irbesartan arm in NCT03493685, the eGFR slope was -5.7 milliliters/minute/1.73square meter/year.

For patients with IgA Nephropathy (IgAN), the PROTECT study (NCT03762850) investigated Sparsentan against irbesartan. The primary endpoint for this study was the percent change from baseline in the urine protein/creatinine (UP/C) at Week 36. In the Sparsentan arm of NCT03762850, the geometric least squares mean percent change from baseline in UP/C was -49.77%. For the irbesartan arm in NCT03762850, the geometric least squares mean percent change from baseline in UP/C at Week 36 was -15.05%.

All values presented here are sourced from primary registry reporting. Individual clinical papers should be consulted for comprehensive details and clinical decision-making.

All Sparsentan publications (15)

2026 (3 papers)

  1. Antiproteinuric Effect of Sparsentan in Patients with Genetic-Associated FSGS Enrolled in the DUPLEX Trial.
    Yee J, Gong W, Inrig J, et al. · Clin J Am Soc Nephrol · 2026 · Derived
    PubMed: PMID 41433094 · NCT03493685 (DUPLEX) · Glomerulosclerosis, Focal Segmental
  2. Treatment Approaches for Alport Syndrome.
    Rheault MN · J Am Soc Nephrol · 2026 · Derived
    PubMed: PMID 40938675 · NCT05003986 (EPPIK) · Glomerulonephritis, IGA
  3. Association between Complete Proteinuria Remission and Kidney Function in the Phase 3 PROTECT Trial of Sparsentan in IgA Nephropathy.
    Heerspink HJL, Rovin BH, Komers R, et al. · Clin J Am Soc Nephrol · 2026 · Derived
    PubMed: PMID 41428405 · NCT03762850 (PROTECT) · Glomerulonephritis, IGA

2025 (1 paper)

  1. Interventions for idiopathic steroid-resistant nephrotic syndrome in children.
    Liu ID, Willis NS, Craig JC, et al. · Cochrane Database Syst Rev · 2025 · Derived
    PubMed: PMID 40337980 · NCT01613118 (DUET) · Glomerulosclerosis, Focal Segmental

2024 (3 papers)

  1. Sparsentan for Focal Segmental Glomerulosclerosis in the DUET Open-Label Extension: Long-term Efficacy and Safety.
    Campbell KN, Gesualdo L, Murphy E, et al. · Kidney Med · 2024 · Trial result
    PubMed: PMID 38831932 · NCT01613118 (DUET) · Glomerulosclerosis, Focal Segmental
  2. Non-immunosuppressive treatment for IgA nephropathy.
    Tunnicliffe DJ, Reid S, Craig JC, et al. · Cochrane Database Syst Rev · 2024 · Derived
    PubMed: PMID 38299639 · NCT03762850 (PROTECT) · Glomerulonephritis, IGA
  3. Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis.
    Rheault MN, Alpers CE, Barratt J, et al. · N Engl J Med · 2024 · Derived
    PubMed: PMID 37921461 · NCT03493685 (DUPLEX) · Glomerulosclerosis, Focal Segmental

2023 (4 papers)

  1. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial.
    Rovin BH, Barratt J, Heerspink HJL, et al. · Lancet · 2023 · Derived
    PubMed: PMID 37931634 · NCT03762850 (PROTECT) · Glomerulonephritis, IGA
  2. PPAR δ Agonism Ameliorates Renal Fibrosis in an Alport Syndrome Mouse Model.
    Omachi K, O'Carroll C, Miner JH, et al. · Kidney360 · 2023 · Derived
    PubMed: PMID 36657027 · NCT01613118 (DUET) · Glomerulosclerosis, Focal Segmental
  3. Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations.
    Obadina M, Wilson S, Derebail VK, et al. · Kidney360 · 2023 · Derived
    PubMed: PMID 37254256 · NCT03493685 (DUPLEX) · Glomerulosclerosis, Focal Segmental
  4. Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial.
    Heerspink HJL, Radhakrishnan J, Alpers CE, et al. · Lancet · 2023 · Derived
    PubMed: PMID 37015244 · NCT03762850 (PROTECT) · Glomerulonephritis, IGA

2022 (2 papers)

  1. Interventions for focal segmental glomerulosclerosis in adults.
    Hodson EM, Sinha A, Cooper TE, et al. · Cochrane Database Syst Rev · 2022 · Derived
    PubMed: PMID 35224732 · NCT01613118 (DUET) · Glomerulosclerosis, Focal Segmental
  2. Arterial stiffness, endothelial dysfunction and impaired fibrinolysis are pathogenic mechanisms contributing to cardiovascular risk in ANCA-associated vasculitis.
    Farrah TE, Melville V, Czopek A, et al. · Kidney Int · 2022 · Background
    PubMed: PMID 35998848 · NCT05630612 (SPARVASC) · Kidney Diseases

2019 (1 paper)

  1. DUET: A Phase 2 Study Evaluating the Efficacy and Safety of Sparsentan in Patients with FSGS.
    Trachtman H, Nelson P, Adler S, et al. · J Am Soc Nephrol · 2019 · Trial result
    PubMed: PMID 30361325 · NCT01613118 (DUET) · Glomerulosclerosis, Focal Segmental

2011 (1 paper)

  1. Focal segmental glomerulosclerosis.
    D'Agati VD, Kaskel FJ, Falk RJ, et al. · N Engl J Med · 2011 · Background
    PubMed: PMID 22187987 · NCT01613118 (DUET) · Glomerulosclerosis, Focal Segmental

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).